Field Safety Notice Pennine Nasogastric Devices, Suction Catheters, Rectal Tubes and Nelaton Catheters Multiple Products (ICN 1441)

MHRA: 2021/011/003/579/010
NHSSC Ref: 57

Alert:

• Following two reports stating that the manufactured Nasogastric tubing does not have side eyes (holes )Pennine has issued an Urgent Field Safety Notice to advise users to visually inspect the nasogastric devices listed above for side eyes and not to use if the side eyes are missing.
• The device is intended for administration and/or aspiration of gastric fluids or gas out of the stomach Using a defective device (with no side eyes) may cause serious injury to the patient. While the defect rate is very low (as per Pennine’s records), it is important that all users follow the Instructions for Use (supplied with Gastric Access devices- Ryles Tubes, Levins Tubes and Feeding Tubes) and check the product for defects prior to use.
• Other products listed in the FSN are manufactured using the same machine. The manufacturer has not received any complaint related to missing side eyes on these products. However, they recommend following the same instructions as above before using them.

Products Affected:

• A number of these products are available from NHS Supply Chain, see our Downloads section for affected product information.
• Current stock in NHS Supply Chain Depots is in the process of being checked. Affected lot numbers will be quarantined for return to Pennine. Please be aware until this is complete deliveries may still be made of affected devices, it is essential you perform the visual checks.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete and return the Customer Reply Form (Appendix C) as directed.
• Where affected product without side eyes are identified, do not use, quarantine, and contact recalls@penninehealthcare.co.uk
• Please also contact your local NHS Supply Chain Customer Service Advisor with the full details to enable us to manage credit as appropriate on your behalf.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.