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

Catalog Number 66000708

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event 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.

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
• Type of Device: 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
• MDR Text Key: 288176369
• Report Number: 8043484-2022-00116
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223441227
• UDI-Public: 5000223441227
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 66000708
• Device Lot Number: 202127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1