MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX 10CMX10M CTN 1; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66000041
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, during a treatment setup, an opsite flexifix 10cmx10m ctn 1 was impossible to unroll because a part of the release paper has been adhered to the transparent carrier of inside part of the roll, due to excessive adhesive on the backside of the release paper.Treatment was completed with a backup device.No delay was reported.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
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.A complaint history review found a small number of similar instances of the reported event.There is nothing to indicate that this is outside of acceptable rates of occurrence.The device intended for use in treatment was returned for evaluation and was found to be as described in the complaint.We have been able to confirm a relationship between the event and the device.It was reported that the film stuck to the backing paper and could not be unrolled.Probable root cause is an environmental issue such as temperature.Changes in temperature can alter the adhesive nature of the device.The device must be stored as per the ifu.The users of the reported product are advised to consult the ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device and the conditions in which the device must be stored.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 FLEXIFIX 10CMX10M CTN 1
• 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: 12544884
• Report Number: 8043484-2021-01811
• Device Sequence Number: 14742281
• Product Code: KGX
• UDI-Device Identifier: 05000223411473
• UDI-Public: 5000223411473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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 Expiration Date: 03/01/2024
• Device Catalogue Number: 66000041
• Device Lot Number: 2110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1