MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER LITE 10X10CM; DRESSING,WOUND,OCCLUSIVE

Model Number	66020408
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, during treatment, when a sterile pouch of an allevyn gentle border lite 10x10cm was taken out, it was noticed that there was an 8 cm size unsealed part on one side edge.Treatment was completed with a sn back-up dressing.No harm to the patient or further complications reported.
Additional Manufacturer Narrative
Section h3, h6: 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 curled and captured 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.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.The complaint history review confirms previous complaints of this nature with manufacturing problems observed.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.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 10X10CM
• 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: 13896538
• Report Number: 8043484-2022-00112
• Device Sequence Number: 4240472
• Product Code: NAD
• UDI-Device Identifier: 05000223475499
• UDI-Public: 05000223475499
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: 66020408
• Device Catalogue Number: 66800835
• Device Lot Number: 202128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 08/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown