MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE INCISE 15X28CM CTN 10; TAPE AND BANDAGE, ADHESIVE

Model Number	4986
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up or inspection, it was impossible to remove the release paper of the opsite because it adhered to the film strongly.The procedure was completed without a significant delay using a smith & nephew back-up device.No other complications were reported.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.The device intended to be used in treatment has been returned and evaluated.A relationship between the event and the device was confirmed.An initial visual inspection confirmed that the pouch was completely sealed all around.The root cause was determined as the paper slightly moving backward when the machine start-up or restart, causing the cutting position to fall in the sealed area.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events.The machine start parameter setting had been optimized to avoid the above issue.No further actions are deemed necessary at this stage.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 INCISE 15X28CM 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
• MDR Report Key: 11429734
• Report Number: 8043484-2021-00463
• Device Sequence Number: 19737725
• Product Code: KGX
• UDI-Device Identifier: 05000223415495
• UDI-Public: 05000223415495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/26/2021

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 Model Number: 4986
• Device Catalogue Number: 4986
• Device Lot Number: 202019
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1