MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST-OP VISIBLE 16X11CM JP CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800144

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

When release papers were removed, it was confirmed there was no adhesive on the dressing, so it could not be used.A backup was available.No delay was reported.

Manufacturer Narrative

We have now completed our investigation into the reported complaint.A review of the batch manufacturing records could not be performed as the lot number was not provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out using the part number provided, there have been no further complaints reported with this failure mode in the past three years.The device was intended for use in treatment.The complaint sample was returned for inspection, and visual inspection was carried out which confirmed the issue of film lack of adhesive.This confirmed a relationship between the device and the event reported.This is raw material defect.There are checks in place to prevent lacking adhesive of the film.If this issue is identified during in-process checks, it is tabbed and recorded in the fault log.On this occasion the operator appears to have missed the issue.Lacking adhesive sometimes occur in the film during the adhesive application process at the start or end of the roll.As the occurrence of this failure mode is within acceptable range, 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.

• Brand Name: OPSITE POST-OP VISIBLE 16X11CM JP CTN 20
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10821155
• MDR Text Key: 215868271
• Report Number: 8043484-2020-03841
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111152091
• UDI-Public: 4582111152091
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

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: 66800144
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1