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

Model Number	420680
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	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial 2 of 10.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
The wound care nurse reported that she had discovered an extra foreign object under the silicone border of the bandage.The product had not been used.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H3: device evaluated by manufacturer? has been selected as yes.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 sampling was satisfactory.Aquacel foam adh 10x10cm(1x10) eur was manufactured under system application product (sap) code 1705400 and lot number 4f03751 manufactured on 26/jun/2024.Lot # 4f03751 was sterilised under work order (b)(4) and released on review of results of sterilisation provided by sterilisation company sterigenics.All results were within specification and products were released.No nonconformity was registered during the manufacturing process of lot 4f03751.This was the only complaint for the affected lot registered within the database.One photograph was received for this issue and had been evaluated in accordance with work instructions (wi).The photograph confirms the expected product and complaint issue, where brown foreign matter was identified in the silicone border.The complaint sample was requested on 27/may/2025 and received at deeside on 09/jun/2025.The complaint description identified 10 affected units, but the complaint originator and the attached complaint intake form confirm a single dressing was affected by this issue.This was confirmed at the point of requesting the complaint samples, as the initial request for all 10 affected dressings was rejected as only a single dressing was involved.Corrective and preventive actions (capa) was not raised for this issue as it was identified to be below acceptable quality level (aql).The acceptable quality level (aql) from process instruction (pi) identify contamination as 0.40, with an accept 5 and reject 6 based upon a sample of 500 secondary packs and batch size of 9720 secondary packs.As zero packs remain in distribution center (dc), it was likely over 500 packs have been exhausted.A single primary pack had been reported for foreign matter, so this issue remains below acceptable quality level (aql) and no corrective and preventive actions (capa) was necessary at this time.The complaint dressing was inspected upon receipt.The foreign object appears slightly translucent and pink/brown in color.It was located between the polyurethane film (pu) and silicone layers of the dressing within the border, so it was most likely to have been present in the polyurethane film (pu), the silicone trilaminate or originated from the manufacturing line.It was common for silicone to build up on the rollers of the manufacturing line during manufacture, and it was possible for the silicone buildup to compress to become dense and dark pink in color.In this case, it was most likely that the compressed silicone buildup had become detached from a roller and attached to the silicone adhesive of the dressing.As only a single dressing had been reported for this issue, and no similar foreign objects have been seen before, this was likely an isolated issue.It was likely to have been missed at the final inspection, although the foreign matter will have been facing the inside of the primary pack and therefore facing away from the operators, so it would be difficult to see at validated line speeds.The complaint will be shared with operators for awareness.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, additional patient or event details were received which have been added in h11 (addl mfg narrative).

• 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; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 22170349
• Report Number: 1000317571-2025-00046
• Device Sequence Number: 12720021
• Product Code: NAC
• UDI-Device Identifier: 00768455127115
• UDI-Public: 00768455127115
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: Health Professional
• Device Model Number: 420680
• Device Lot Number: 4F03751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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