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

Model Number	420642
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	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 1 of 2 e1: complainant street address: (b)(6) complainant country: philippines.Name of affiliation: (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 there were two pieces of dressings with colored dots.The product was not used by patient.The 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 h11: investigation summary: a batch record review was completed and no discrepancies were found.All in-process stat sample quality checks were satisfactory.Aquacel foam ag n/adh10x10 (1x10) nai was manufactured under system application product (sap) code 1704015 and manufacturing lot number: 4f05552 on 01 july 2024.Lot#: 4f05552 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: 4f05552.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, product and the complaint issue where foreign matter in the form of a dark dot is seen on the external pink polyurethane (pu) of two dressings.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) being raised.The 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), in which three types of contaminants were identified and mitigation plans put in place by the supplier.Capa remains open for effectiveness checks to be completed.The lot under complaint is confirmed as within bounding of this capa, communicated to the capa owner on 06 january 2025.The acceptable quality levels (aqls) from process instruction (pi) identify contamination as 0.40, with an accept 5 and reject 6 based upon a sample of 500 dressings and batch size of (b)(4) dressings ((b)(4) secondary packs).As only (b)(4) packs remain in distribution centers (dcs), it is likely over 500 dressings have been exhausted, and as only two dressings have been reported for foreign matter, the issue remains below aqls.The dressings are inspected by operators during manufacture, but as the foreign matter is of such a small size (estimated max 1mm in diameter), this foreign matter would have been difficult to identify on human inspection at validated line speeds.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 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: 21215786
• Report Number: 1000317571-2025-00001
• Device Sequence Number: 18341866
• Product Code: FRO
• UDI-Device Identifier: 00768455123889
• UDI-Public: 768455123889
• 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): 12/30/2024

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: 420642
• Device Lot Number: 4F05552
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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