MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIGRID BULK 6X7CM CASE 2100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66000376
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when they opened the box noticed that one of the dressing did not have adhesive on it.No case involved.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as the lot number provided is not a recognized lot number format for this product, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains no further instances/ related events of the reported event.The device was intended for use in treatment.As no samples were returned a thorough product evaluation could not be carried out.Low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.We have not been able to confirm a relationship between the event and the device.The root cause remains undetermined.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.A review of the batch manufacturing records has been completed and there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains no further instances/ related events of the reported event.The device was intended for use in treatment.A visual inspection was completed in which it was confirmed that 1 dressing returned had no adhesive present on the dressing.We have been able to confirm a relationship between the event and the device.The root cause has been established as a manufacturing error.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: OPSITE FLEXIGRID BULK 6X7CM CASE 2100
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10819722
• Report Number: 8043484-2020-03814
• Device Sequence Number: 19111121
• Product Code: KGX
• UDI-Device Identifier: 05000223415402
• UDI-Public: 05000223415402
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2021

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: 66000376
• Device Lot Number: 201041-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 04/16/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/17/2020; 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1