MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIGRID 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4628
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, during wound treatment, there were many black spots in the film after opening the package.It was found in six (6) boxes of opsite flexigrid 6x7cm ctn 100.Treatment was resumed, without any delay, with a smith and nephew back-up device.Patient is fine and was not harmed.No further complications reported.
Additional Manufacturer Narrative
H3, h6; it was reported that, during wound treatment, there were many black spots in the film after opening the package.It was found in six (6) boxes of opsite flexigrid 6x7cm ctn 100.Treatment was resumed, without any delay, with a smith and nephew back-up device.Patient is fine and was not harmed.No further complications reported.The device was returned for analysis and was submitted to surface analysis for examination.Microscopic analysis revealed that the black coloured staining was believed to be crystallised cleaning product, of an unspecified nature.We have therefore been able to confirm a relationship between the event and the device, however, cannot identify a definitive root cause.A lot number was provided and the batch records were reviewed.It was confirmed that the product(s) 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.(despite repeated attempts, smartsolve would not save the separate dhr task) a complaint history review (chr) revealed a very small number of similar instances in the last 12 months.A risk management review was conducted and which mitigated the reported issue with no further action or updates required.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.A review concluded that there are no prior escalated actions related to this product and the reported event.The probable root cause for this complaint is that the markings on the device(s) have been placed there during the manufacturing process.The machines involved are cleaned at regular intervals, and it is believed that liquid cleaning product has been left on a component part of the machine, which has then been transferred to the device(s).This liquid has then crystallised as a result of the remaining manufacturing processes which take place, resulting in the markings as described.Investigations into this complaint are now complete and no further actions by smith & nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith & nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: OPSITE FLEXIGRID 6X7CM CTN 100
• 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 dr; austin, TX 78735 ; 5123913905
• MDR Report Key: 14291725
• Report Number: 8043484-2022-00148
• Device Sequence Number: 19251368
• Product Code: KGX
• UDI-Device Identifier: 05000223046286
• UDI-Public: 5000223046286
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: 07/01/2025
• Device Catalogue Number: 4628
• Device Lot Number: 2028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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