MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 6.5X5CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66000708
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during set up for wound treatment, it was confirmed there was a foreign substance on the wound-contact side of three dressings of a opsite post op 6.5x5cm ctn 100.As this was noticed before treatment, there was not any patient involved.
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.The assessment confirmed there was a foreign substance embedded in the wound-contact layer of the pad.A manufacturing process review was carried out.The pad supplied by a third party with film and handle laminated into a dressing, and this light-colored contamination cannot be detected by detection equipment during the production process.The root cause was identified as a raw material defect.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 no manufacturing problems observed.The risk files mitigate the reported issue with no updates required.A review of prior escalation actions found no actions applicable to the scope of this case.We have communicated with the pad supplier that this investigation is now complete and no further action is necessary.Smith and nephew will continue to monitor any adverse trends associated with this product line.

• Brand Name: OPSITE POST OP 6.5X5CM CTN 100
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• 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: 13945792
• Report Number: 8043484-2022-00116
• Device Sequence Number: 20459524
• Product Code: KGX
• UDI-Device Identifier: 05000223441227
• UDI-Public: 5000223441227
• 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): 07/18/2022

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 Catalogue Number: 66000708
• Device Lot Number: 202127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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