Infokiri

Devices Report Report ID: 2024/002/026/601/060

Administrative information

To which NCA(s) is this report being sent?

MHRA

Date of this report

2024-02-26

Type of Report

Initial

Reference assigned by the manufacturer

FSN 001/24

FSCA reference number assigned by NCA

2024/002/026/601/060

Incidence reference number assigned by NCA

-

Name of the co-ordinating NCA Competent Authority (if applicable)

-

Information on the submitter of the report

Submitter of report

Manufacturer

Manufacturer information

Manufacturer Organisation name

HMC Premedical spa

Contact Name

Emanuela Govi

E-mail

[email protected]

Phone

+39053522704

Country

Italy

Address

Via Bosco 1/3

City name

Mirandola

Postcode

41037

Authorized representative information

Authorised representative Organisation name

HMC Medical UK Limited

Contact Name

Joanne Schmidt

E-mail

[email protected]

Phone

+441204695050

Country

United Kingdom

Address

Unit 2 Rivington View Business Park

City

Blackrod, Bolton

Postcode

BL6 5BN

National Contact Point Information

National contact point organisation name

HMC Medical UK Limited

Name of the contact person

Joanne Schmidt

E-mail

[email protected]

Phone

+441204695050

Country

GB

Address

Unit 2 Rivington View Business Park

City name

Blackrod, Bolton

Postcode

BL6 5BN

Medical Device Information

Class

MDD Class IIb

Nomenclature system (preferable GMDN)

GMDN

Medical device nomenclature code

64616

Nomenclature text

ENFit double-lumen polyurethane “Replogle” tube

Commercial name/brand name/make

ENFit double-lumen polyurethane “Replogle” tube

Model

NF02L

Catalogue/Reference number

NF02L

Serial number(s)

-

Lot/batch number(s)

19I09004 21F18002 23C03045 23C03046

Device manufacturing date

-

Device expiry date

-

Notified body (NB) ID number(s) (if applicable

)

-

Details of additional devices/ accessories

involved in the incident

-

Software version (if applicable)

-

Description of FSCA

Background information and reason for the

FSCA

The hospital reported that there was a problem with

location of the irrigation holes in the ENFit 10fr

double Lumen Replogle Tube with a neonate patient.

When the tube was in situ in the patient, and saline

was administered for irrigation, the saline came out

of the first hole in the tube, which is (roughly) 7cm

from the end of the tube . The patient that required

the tube has an oesophageal atresia 9.5cm down

from her mouth meaning that the tube was only

inserted to 9.5cm. The result was that the saline

came out (roughly) 3cm away from her mouth which

was likely above the epiglottis and a huge risk of

aspiration. This also meant that the patient

secretions were not loosened and blocked the

suction holes.

Description and justification of the action

(corrective / preventive)

The defective sample is not available for

investigation. Since the device was put on the

market, we have never received similar complaint.

From the feedback received from the hospital, the

appropriate procedure was followed for the use of

the device. The reporter identified a difference in the

position of the holes in the device, compared with

the competitor device (Cardinal Health Replogle

Tube). The position of the holes on the competitor

device is closer to the end of the tube the first hole

being roughly 2cm from the end of the tube. We

cannot eliminate the possibility that the location of

the holes on the tube contributed to the

complications experienced by the patient. Without

access to the tubes subject to the complaint but

based on the available information from the reporter

it is not possible to exclude the possibility that the

design of this device resulted in the complications

the patient experienced. For this reason, the decision

has been taken to initiate a recall. The product will

be placed in quarantine, and the recall notice will be

issued. The product will be withdrawn from the

market and no new batches of the product will be

placed on the market.

Advice on actions to be taken by the

distributor and the user

Users should contact Medicina who will arrange

collection and destruction of the batches specified.

Progress of FSCA, together with reconciliation

data

-

Time schedule for the implementation of the

different actions

Subject to approval of draft FSCA by MHRA,

notifications to all customers in territory can be sent

within 5 working days of approval, follow-up every 7

working days thereafter

Attached Please Find

Field Safety Notice (FSN) in English

FSN status

Final FSN

Attachments

File Name

FSN 001/24

All EEA, Great Britain, candidate countries and

Switzerland

-

Distribution (Multiple choice)

-

Other Countries (including Northern Ireland)

-

Comments

Comments

Incident also reported MHRA code 2024/002/026/601/052.

Devices Report Report ID: 2024/002/026/601/060

Administrative information

To which NCA(s) is this report being sent?

MHRA

Date of this report

2024-02-26

Type of Report

Initial

Reference assigned by the manufacturer

FSN 001/24

FSCA reference number assigned by NCA

2024/002/026/601/060

Incidence reference number assigned by NCA

-

Name of the co-ordinating NCA Competent Authority (if applicable)

-

Information on the submitter of the report

Submitter of report

Manufacturer

Manufacturer information

Manufacturer Organisation name

HMC Premedical spa

Contact Name

Emanuela Govi

E-mail

[email protected]

Phone

+39053522704

Country

Italy

Address

Via Bosco 1/3

City name

Mirandola

Postcode

41037

Authorized representative information

Authorised representative Organisation name

HMC Medical UK Limited

Contact Name

Joanne Schmidt

E-mail

[email protected]

Phone

+441204695050

Country

United Kingdom

Address

Unit 2 Rivington View Business Park

City

Blackrod, Bolton

Postcode

BL6 5BN

National Contact Point Information

National contact point organisation name

HMC Medical UK Limited

Name of the contact person

Joanne Schmidt

E-mail

[email protected]

Phone

+441204695050

Country

GB

Address

Unit 2 Rivington View Business Park

City name

Blackrod, Bolton

Postcode

BL6 5BN

Medical Device Information

Class

MDD Class IIb

Nomenclature system (preferable GMDN)

GMDN

Medical device nomenclature code

64616

Nomenclature text

ENFit double-lumen polyurethane “Replogle” tube

Commercial name/brand name/make

ENFit double-lumen polyurethane “Replogle” tube

Model

NF02L

Catalogue/Reference number

NF02L

Serial number(s)

-

Lot/batch number(s)

19I09004 21F18002 23C03045 23C03046

Device manufacturing date

-

Device expiry date

-

Notified body (NB) ID number(s) (if applicable

)

-

Details of additional devices/ accessories

involved in the incident

-

Software version (if applicable)

-

Description of FSCA

Background information and reason for the

FSCA

The hospital reported that there was a problem with

location of the irrigation holes in the ENFit 10fr

double Lumen Replogle Tube with a neonate patient.

When the tube was in situ in the patient, and saline

was administered for irrigation, the saline came out

of the first hole in the tube, which is (roughly) 7cm

from the end of the tube . The patient that required

the tube has an oesophageal atresia 9.5cm down

from her mouth meaning that the tube was only

inserted to 9.5cm. The result was that the saline

came out (roughly) 3cm away from her mouth which

was likely above the epiglottis and a huge risk of

aspiration. This also meant that the patient

secretions were not loosened and blocked the

suction holes.

Description and justification of the action

(corrective / preventive)

The defective sample is not available for

investigation. Since the device was put on the

market, we have never received similar complaint.

From the feedback received from the hospital, the

appropriate procedure was followed for the use of

the device. The reporter identified a difference in the

position of the holes in the device, compared with

the competitor device (Cardinal Health Replogle

Tube). The position of the holes on the competitor

device is closer to the end of the tube the first hole

being roughly 2cm from the end of the tube. We

cannot eliminate the possibility that the location of

the holes on the tube contributed to the

complications experienced by the patient. Without

access to the tubes subject to the complaint but

based on the available information from the reporter

it is not possible to exclude the possibility that the

design of this device resulted in the complications

the patient experienced. For this reason, the decision

has been taken to initiate a recall. The product will

be placed in quarantine, and the recall notice will be

issued. The product will be withdrawn from the

market and no new batches of the product will be

placed on the market.

Advice on actions to be taken by the

distributor and the user

Users should contact Medicina who will arrange

collection and destruction of the batches specified.

Progress of FSCA, together with reconciliation

data

-

Time schedule for the implementation of the

different actions

Subject to approval of draft FSCA by MHRA,

notifications to all customers in territory can be sent

within 5 working days of approval, follow-up every 7

working days thereafter

Attached Please Find

Field Safety Notice (FSN) in English

FSN status

Final FSN

Attachments

File Name

FSN 001/24

All EEA, Great Britain, candidate countries and

Switzerland

-

Distribution (Multiple choice)

-

Other Countries (including Northern Ireland)

-

Comments

Comments

Incident also reported MHRA code 2024/002/026/601/052.

Field Safety Corrective Action: Product Recall Product Codes:

Brands:

FSN Ref:

Date:

NF02L

ENFit Double Lumen Replogle Tube

FSN-001/24, 2024/002/026/601/060

04/03/2024

Field Safety Corrective Action notice for certain batches of ENFit Double Lumen Replogle Tube

Immediate Attention

All users of ENFit Double Lumen Replogle Tube

Device Description

ENFit Double Lumen Replogle Tubes are used in Neonatal units to aspirate and irrigate fluids in conditions such as oesophageal atresia.

ENFit Double Lumen Replogle Tube

Reason for product recall

HMC and Medicina is voluntarily recalling the batches of the product listed below due to a potential design issue that has been established that has the potential to impact the health and safety of the patient. As a result of the investigation, the decision has been taken to initiate a recall.

Recalled Product Code, Description and Batch Numbers

Code Description Batches

NF02L ENFit Double Lumen Replogle Tube 10FR

19I09004 21F18002 23C03045 23C03046

Action to be taken

- Please carefully read this Field Safety Notice and return the Acknowledgement Form

- Please do not use any of the batches of product listed on this notice

- If you have product to return, please complete the information on the Acknowledgement Form and our team will contact you for the material management

- Please distribute throughout your organisations and to relevant personnel

- If you have any questions or queries in relation to this notice, please contact us using the information below

Contact information regarding FSN

For Italy and Danmark For All other countries Emanuela Govi Complaints coordinator Email: [email protected] Tel: +39 0535 22704

Shaista Patel QA/RA Administrator Email: [email protected] Tel: 01204 695050

Acknowledgement Form: FSN-001/24 Field Safety Corrective Action

Product Codes: NF02L

Brands: ENFit Double Lumen Replogle Tube

Please confirm you have received the notice by completing this form and returning it to us by post or email as soon as possible.

Acknowledgement

We confirm receipt of this Field Safety Notice FSN-001/24 and that this is received, read, and distributed to anyone it may concern within our organisation and/or to our customers (for distributors).

Organisation Name:

Department:

Representative Name and Signature:

Date:

Product to be returned: Yes / No

Contact details to arrange return:

Please return the Acknowledgement Form to:

For Italy and Danmark For All other countries Emanuela Govi Complaints coordinator Email: [email protected] Tel: +39 0535 22704

Shaista Patel QA/RA Administrator Email: [email protected] Tel: 01204 695050

Field Safety Corrective Action: Product Recall Product Codes:

Brands:

FSN Ref:

Date:

NF02L

ENFit Double Lumen Replogle Tube

FSN-001/24, 2024/002/026/601/060

04/03/2024

Field Safety Corrective Action notice for certain batches of ENFit Double Lumen Replogle Tube

Immediate Attention

All users of ENFit Double Lumen Replogle Tube

Device Description

ENFit Double Lumen Replogle Tubes are used in Neonatal units to aspirate and irrigate fluids in conditions such as oesophageal atresia.

ENFit Double Lumen Replogle Tube

Reason for product recall

HMC and Medicina is voluntarily recalling the batches of the product listed below due to a potential design issue that has been established that has the potential to impact the health and safety of the patient. As a result of the investigation, the decision has been taken to initiate a recall.

Recalled Product Code, Description and Batch Numbers

Code Description Batches

NF02L ENFit Double Lumen Replogle Tube 10FR

19I09004 21F18002 23C03045 23C03046

Action to be taken

- Please carefully read this Field Safety Notice and return the Acknowledgement Form

- Please do not use any of the batches of product listed on this notice

- If you have product to return, please complete the information on the Acknowledgement Form and our team will contact you for the material management

- Please distribute throughout your organisations and to relevant personnel

- If you have any questions or queries in relation to this notice, please contact us using the information below

Contact information regarding FSN

For Italy and Danmark For All other countries Emanuela Govi Complaints coordinator Email: [email protected] Tel: +39 0535 22704

Shaista Patel QA/RA Administrator Email: [email protected] Tel: 01204 695050

Acknowledgement Form: FSN-001/24 Field Safety Corrective Action

Product Codes: NF02L

Brands: ENFit Double Lumen Replogle Tube

Please confirm you have received the notice by completing this form and returning it to us by post or email as soon as possible.

Acknowledgement

We confirm receipt of this Field Safety Notice FSN-001/24 and that this is received, read, and distributed to anyone it may concern within our organisation and/or to our customers (for distributors).

Organisation Name:

Department:

Representative Name and Signature:

Date:

Product to be returned: Yes / No

Contact details to arrange return:

Please return the Acknowledgement Form to:

For Italy and Danmark For All other countries Emanuela Govi Complaints coordinator Email: [email protected] Tel: +39 0535 22704

Shaista Patel QA/RA Administrator Email: [email protected] Tel: 01204 695050