MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN THIN 10X10CM CTN 5; DRESSING,WOUND,OCCLUSIVE

Model Number	66047578
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the package of allevyn thin was found open when it was going to be used to fix the catheter.Back up device was available.No harm to the patient reported.
Additional Manufacturer Narrative
It was reported that the package of allevyn thin was found open when it was going to be used to fix the catheter.Back up device was available.No harm to the patient reported.The device was used for treatment and was not returned for analysis, nor were any photographs provided.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.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 no similar instances in the last three years.The risk files, mitigate the reported issues with no updates required.As the event described was reported to have been found during treatment and not set up, the most probable root cause is that the dressing had been previously opened and returned to the box.If the issue had been noticed due to set up, it may have been more likely due to a manufacturing issue, but the issue had not been noted during set up.There are strict quality checks in place during manufacture to prevent any fault dressing or pouch leaving manufacture.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.

• Brand Name: ALLEVYN THIN 10X10CM CTN 5
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• 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: 13656155
• Report Number: 8043484-2022-00086
• Device Sequence Number: 5801026
• Product Code: NAD
• UDI-Device Identifier: 05000223452919
• UDI-Public: 05000223452919
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/10/2022

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: 06/01/2023
• Device Model Number: 66047578
• Device Catalogue Number: 66047578
• Device Lot Number: 2023
• 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: 02/13/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/10/2022
• Date Device Manufactured: 06/01/2020
• 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