MAUDE Adverse Event Report: CONVATEC LTD AQUACEL AG+ EXTRA; DRESSING, WOUND, DRUG

Model Number	413568
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
Additional Manufacturer Narrative
Device 5 of 14.Initial reporter (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 1000317571.
Event or Problem Description
It was reported that complainant found an unglued (opened) package on the weld.It was unknown whether the product was used on patient or not.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
Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary a batch record review was completed, and no discrepancies were found.Aquacel foam adh 21x21(1x5) cee was manufactured under system application product (sap) code 1703947 and lot number 2b02842 manufactured on 20 february 2022.Lot # 2b02842 was sterilized under work order (b)(4) and released on review of results of sterilization provided by sterilization company steris.All results were within specification and products were released.No nonconformity was registered during the manufacturing process of lot 2b02842.This is the only complaint for the affected lot registered within database.Three photographs were received for this issue and have been evaluated in accordance with work instruction (wi).The photographs confirm the expected lot number, product and complaint issue.The foreign matter was a hair that can be seen on the top right corner of the dressing within the primary pack.The hair was visible but not immediately noticeable in the first image.A previous non-conformance (nc) record was raised for foreign matter hair, and an investigation completed to identify the how the foreign matter had gotten into the primary sachet.It was confirmed current personal protective equipment (ppe) was suitable for use in the controlled environment, but it does allow movement which may allow loose hairs to transfer onto garments and in turn may transfer onto material and products while working in the controlled environment.Hair may also be transferred from supplier materials which cannot be ruled out as a possible cause.Good manufacturing practice (gmp) audits are regularly conducted to ensure all good manufacturing practice (gmp) activities are being followed, and that during these good manufacturing practice (gmp) audits, relevant personnel will be reminded of the gowning up requirements on a regular basis.No further actions are required as part of this non-conformance (nc).Awareness training has been completed for relevant shifts on this complaint issue and images received, although it is acknowledged that the hair would not have been easily identifiable when the dressings have been manually inspected during manufacture.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 1000317571.

• Brand Name: AQUACEL AG+ EXTRA
• 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: 17036922
• Report Number: 1000317571-2023-00092
• Device Sequence Number: 6459447
• Product Code: FRO
• UDI-Device Identifier: 00768455132034
• UDI-Public: 00768455132034
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 05/11/2023

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: Other
• Device Expiration Date: 12/01/2024
• Device Model Number: 413568
• Device Catalogue Number: 413568
• Device Lot Number: 2M01377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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