MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX 5CMX10M CTN 1; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66000040
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up for treatment, an opsite flexifix 5cmx10m ctn 1 was impossible to unroll because there was some adhesive on the backside of the release paper.When the customer tried to unroll to use, the release paper was torn up.Treatment was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Postal code: (b)(6).
Additional Manufacturer Narrative
H10: it was reported that during set up it was impossible to unroll the opsite flexifix because there was some adhesive ion the back of the release paper and when the customer tried to unroll to use, the release paper was torn up.The device was used for treatment and was not returned for analysis, however a comprehensive photograph was provided which established a relationship between the event and the device.The batch records were 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 revealed a small number of similar instances in the last three years.The risk files, mitigate the reported issues with no updates required.Probable root cause is an environmental factor such as temperature, due to the device not being stored in the correct conditions.A rise in temperature can affect the adhesive nature of the dressing which can cause issues of this type.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct conditions in which the device must be stored.This investigation is now complete, with no corrective actions required.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 internal complaint reference number: (b)(4).

• Brand Name: OPSITE FLEXIFIX 5CMX10M 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12974534
• Report Number: 8043484-2021-02009
• Device Sequence Number: 19902915
• Product Code: KGX
• UDI-Device Identifier: 05000223411466
• UDI-Public: 5000223411466
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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: 66000040
• Device Lot Number: 2109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown