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

Catalog Number	66000041
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up or inspection the opsite flexifix 10cmx10m ctn 1 was creased.The procedure was completed using the same device.No case involved.
Additional Manufacturer Narrative
H3, h6: 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 was not used for treatment and was returned for analysis.The roll was creased and was coming away from the carrier paper at one side, thus establishing a relationship between the event and the device.It has not been possible to identify a definitive root cause.Probable root cause is damaged caused during the packing of the roll within the carton during manufacture.Quality checks are in place to prevent damaged goods leaving the production site and so this may be as a result of a missed quality check.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: 11773627
• Report Number: 8043484-2021-01004
• Device Sequence Number: 14514242
• Product Code: KGX
• UDI-Device Identifier: 05000223411473
• UDI-Public: 5000223411473
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N/A
• 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): 10/14/2021

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: 09/01/2023
• Device Catalogue Number: 66000041
• Device Lot Number: 2037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1