Field Safety Notice BioDesign Fistula Plug Labelled Expiration Date Incorrect (ICN 2641)

MHRA TBC

NHSSC Ref: 37

Alert:

• Cook Medical has issued an Urgent Field Safety Notice following discovery of a discrepancy between the correct product shelf life and that printed on the finished product label.
• The affected products expire before the expiration date shown on the product labelling.
• Cook Medical advise there is no increased risk to patients for devices used prior to their actual expiry date, and no new risks identified for devices used after their actual expiry date.
• There is potential for an increase in probability of harm relating to already identified adverse events which include impaired hearing, device migration, persistence, pain, discharge, inflammation, abscess, allergic reaction, fever, foreign body reaction, infection and increased procedural time.
• Patient risk will increase if the device is used after the true expiration date.

Products Affected:

• The two products affected are available on the eDirect route via NHS Supply Chain:

• Cook Medical advise the discrepancy was due to an error in the automatic updates of the Enterprise Resource Planning (ERP) System. This has now been rectified.

Next Steps:

Please note, all customers in receipt of affected devices via NHS Supply Chain’s

eDirect route have been contacted individually and should follow the instructions already provided.

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected Lot numbers immediately.
• Complete and return the attached form by email to: fsn@supplychain.nhs.uk by close of play 15 August 2024 if possible, confirming:
  • The products are still unused, and available for collection. Please quote the product, quantity, and Lot number
  • If they have already been used, please note the product, Lot number, and date of operation.
• On receipt of these details the UK Distributor H&R Healthcare will confirm the next steps.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details to enable us to assist where necessary.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.