MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE INCISE 28X30CM CTN 10; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4987
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during set up or inspection for wound treatment, it was noticed that one pouch of a opsite incise 28x30cm ctn 10 had a small hole near the opening of the pouch.The treatment was performed, without any delay, using a s+n back-up dressing.Since incident occurred before procedure; patient was not yet involved.
Additional Manufacturer Narrative
The device was not returned for evaluation.All provided information has been reviewed and we have not been able to confirm a relationship between the device and the reported event or determine a definitive root cause.The manufacturing process was reviewed.Dressings are automatically sealed by machine.There are strict inspections during the manufacturing process to ensure that products that do not meet specifications are rejected.Probable cause includes human inspection failure during the packaging process.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 no additional events of this nature.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: OPSITE INCISE 28X30CM CTN 10
• 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: 18950990
• Report Number: 8043484-2024-00023
• Device Sequence Number: 20602535
• Product Code: KGX
• UDI-Device Identifier: 05000223415501
• UDI-Public: 05000223415501
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 4987
• Device Lot Number: 202328
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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