MAUDE Adverse Event Report: CONVATEC LTD AQUACEL FOAM; DRESSING, WOUND, HYDROPHILIC

Model Number	420635
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (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 by the distributor and pharmacy that there was damage to packaging in one pack.Also, shipping case was normal and not damaged.The product was not used by patient.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 type of investigation, investigation findings, investigation conclusions.A batch record review was completed, and no discrepancies were found.All in-process stat sample quality checks were satisfactory.Aquacel foam n/adh 15x15 (1x5) nai was manufactured under system application product (sap) code 1703996 and manufacturing lot number: 4d05881 on 03 may 2024.Lot#: 4d05881 was sterilized under work order: (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot: 4d05881.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue, evaluated in accordance with work instructions (wi).The images confirm the expected product and lot, as well as the complaint issue where the primary sachet was already open.The photo shows evidence that a seal was originally in place, suggesting the sachet has already been opened by hand.Previous investigation has been completed for dressings with opened seals, raised in corrective and preventive actions (capa): 1808065.This batch is within bounding of the corrective and preventive actions (capa), as checked with the corrective and preventive actions (capa) owner on 12 march 2025.It is likely that the product has been a rejected dressing that returned to the manufacturing line in error.The serialization on the primary sachet shows 11397, towards the end of the manufacturing run.As only a single secondary pack has been affected out of 2880 secondary packs manufactured, this issue will also be below acceptable quality levels (aqls) as stated in process instruction (pi).With an acceptable quality level (aql) of 0.4 for seal integrity, a batch of (b)(4) dressings would accept 3 and reject 4 with a sample size of 315 dressings.As only 121 secondary packs remain in distribution centers (dcs), it is most likely that the sample size has been exhausted.This is the only complaint for this batch and malfunction, so no further investigation is necessary.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 FOAM
• Common Device Name: DRESSING, WOUND, HYDROPHILIC
• 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 27409 ; 3365424679
• MDR Report Key: 21544122
• Report Number: 1000317571-2025-00021
• Device Sequence Number: 8050539
• Product Code: NAC
• UDI-Device Identifier: 00768455123841
• UDI-Public: 00768455123841
• 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): 02/10/2025

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 Model Number: 420635
• Device Lot Number: 4D05881
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• 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