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

Model Number	420627
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant: (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 that one piece of dressing with dirty primary packaging.The product was not used.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
Correction: h4: device manufacture date: in initial emdr, the manufacture date was added as 23 march 2024, but the batch record confirms the manufacture date is 22 march 2024.Hence, it has been corrected.Additional information: this emdr is being submitted to include the below: h4: device manufacture date.H6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary: a batch record review was completed, and no discrepancies were found.All in-process stat sample quality checks were satisfactory.Aquacel foamagadh12.5x12.5 (1x10) nai was manufactured under system application product (sap) code 1703963 and manufacturing lot number: 4c02705 on 22 march 2024.System application product (sap) identifies the manufacture date as 23 march 2024, but the batch record confirms manufacture began on 22 march at 11pm.Lot#: 4c02705 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: 4c02705.This is only complaint for the affected lot registered within database.Two photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the expected lot, product and the complaint issue where foreign matter in the form of a grey, possibly fibrous material is seen on the primary dressing external surface.The complaint sample was not requested for this complaint due to the foreign matter resembling examples from complaint record within the database received from the same complainant, resulting in corrective action / preventive actions (capa): 1888590 being raised.The corrective action / preventive actions (capa) investigation covers 6 previous complaints for foreign matter which have been trended together.During investigation, black dots were also found in the pink pu received from the supplier, confirming that the matter was not originating at convatec.The supplier was issued with supplier corrective action request (scar) 1917085, in which 3 types of contaminants were identified and mitigation plans put in place by the supplier.Corrective action / preventive actions (capa): 1888590 remains open for effectiveness checks to be completed.The lot under complaint is confirmed as within bounding of this corrective action / preventive actions (capa), communicated to the corrective action / preventive actions (capa) owner on 06 jan 2025.The acceptable quality levels (aqls) from process instruction (pi) identify contamination as 0.40, with an accept 2 and reject 3 based upon a sample of 200 dressings and batch size of (b)(4) dressings.As only (b)(4) packs remain in distribution centers (dcs), it is likely over 200 dressings have been exhausted, and as only a single dressing has been reported for foreign matter, this issue also remains below acceptable quality levels (aqls).The dressings are inspected by operators, but as the foreign matter is of a small size, it would have been difficult to spot by human inspection at validated line speeds.There is also the possibility that this is a small piece of ag tow between the pink polyurethane film (pu) and foam layer of the dressing which may not have been grey at the time of the batch production.The foreign matter has a similar color to the ag branding on the dressing surface, so could be mistaken for branding upon first glance if it was visible.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.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: AQUACEL AG FOAM
• 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 27409 ; 3365424679
• MDR Report Key: 21135840
• Report Number: 1000317571-2025-00004
• Device Sequence Number: 12658276
• Product Code: FRO
• UDI-Device Identifier: 00768455123117
• UDI-Public: 00768455123117
• 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): 12/20/2024

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: 420627
• Device Lot Number: 4C02705
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• 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