Field Safety Notice Pajunk GmbH Rectus Sheath NRFit Assembly Issue (ICN 2743)

MHRA TBC

NHSSC : 73

Alert:

• Pajunk has issued a Field Safety Notice having identified an issue with assembly during manufacture of the Rectal Sheath Block MPC 0731163-49 (product code FTR85093).
• The issue means the catheter will not connect securely to the clamping adaptor, making the application of the anesthetic agent impossible.
• The procedure of injection of anesthetic may be delayed, require a re-puncture, or cannot be performed at all due to lack of a connector to an external infusion unit.

Products Affected:

• The affected product is available from NHS Supply Chain:

• NHS Supply Chain have checked their warehouses, all future issues will be of different, unaffected Lot numbers.
• Pajunk advise they have reviewed the assembly process and taken corrective action. Future supplies of unaffected Lot numbers should be available from mid December 2024.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected product.
• Cease use and quarantine the affected Lot number.
• Complete and return the Reply Form, Appendix 2, page 6 of the Field Safety Notice and email to: safety@pajunk.com
• Customers reporting possession of the affected Lot number will be contacted by a Pajunk Representative to arrange supply of a functional Clamping Adaptor.

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.