MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER LITE 7.5X7.5CM; DRESSING,WOUND,OCCLUSIVE

Catalog Number	66800834
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number (b)(4).
Event or Problem Description
It was reported that before use, the allevyn gentle border lite 7.5x7.5cm was noticed to be trapped in the sealing part of the pouch and cut therefore, the dressing was not intact and the sterility of the dressing was compromised.There was no delay and the treatment was finished using a smith & nephew back up.Patient was not harmed.
Additional Manufacturer Narrative
The device was not used in treatment, has been returned and evaluated, establishing a relationship between the device and the reported event.Visual inspection observed the dressing was cut and trapped at the edge of the seal.The root cause has been determined as a quality control deficiency.The dressing skewed after passing camera detection and then trapped in the side seal of pouch.The trapped dressing was not captured by operator during visual inspection.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review revealed a small number of similar events for this nature with manufacturing problems observed.A review of prior escalation actions found no actions applicable to the scope of this case.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN GENTLE BORDER LITE 7.5X7.5CM
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17447376
• Report Number: 8043484-2023-00052
• Device Sequence Number: 7260309
• Product Code: NAD
• UDI-Device Identifier: 05000223475468
• UDI-Public: 05000223475468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/01/2025
• Device Catalogue Number: 66800834
• Device Lot Number: 202250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown