MAUDE Adverse Event Report: CONVATEC LTD L3W0900 - AQUACEL AG; DRESSING, WOUND, DRUG

Model Number	420805
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that primary package was opened.The product was not used.Photographs depicting the issue were received from the complainant.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Aquacel foam ag adh 8x8cm 1x10 nai was manufactured under sap code 1707747 and manufacturing lot number 1bz2108 on 15 feb 2021.Lot # 1bz2108 was sterilised under order 2703791 and released on review of results of sterilisation provided by sterilisation company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 1bz2108.This is the only complaint for the affected lot registered within tw- (b)(4).4 photographs were received for this issue and has been evaluated in accordance with wi-(b)(4).The photographs confirm the expected lot number, product and the complaint issue.Two device primary packages are pictured where the top seals of the primary sachets are open and unsealed.A nonconformance was opened for this complaint issue tw- (b)(4).A data review (tw - (b)(4) was completed, but as other complaints and non-conformances had been raised for similar failures, an investigation was already completed tw- (b)(4) and a capa was already opened for this issue (tw- (b)(4).Capa 1481770 was raised to address findings from child investigation 1468263.Capa was closed on 07-jan-2022.Complaint batch 1g02217 (july-2021), manufactured prior to completion/closure of preventative action 1487809 and correction 1487810 within capa.Capa closed as ¿effective¿.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 1000317571.

• Brand Name: L3W0900 - AQUACEL AG
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 13869030
• Report Number: 1000317571-2022-00069
• Device Sequence Number: 5272527
• Product Code: FRO
• UDI-Device Identifier: 00768455129126
• UDI-Public: 00768455129126
• Combination Product (Y/N): N
• PMA/510(K) Number: K123481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: Other
• Device Expiration Date: 02/01/2023
• Device Model Number: 420805
• Device Catalogue Number: 420805
• Device Lot Number: 1BZ2108
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 08/09/2023
• Date Device Manufactured: 02/15/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown