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

Model Number	421151
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant city: (b)(6) complainant country: finland.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 customer complained regarding a foreign matter inside an unopened sterile dressing which they suspected to be an insect of some kind.The product was not used.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.Based on the available information, this event is deemed to be a reportable malfunction.Complaint code: foreign matter (e.G.Hairs, insects) within primary pack (sterile products) region: finland.Product / system application product (sap): 1710656 aquacel foam adh 10×20 cm (1×10pk) eur lot: 5g05063.Date of manufacture: 25 jul 2025.Sterilization: sterigenics (b)(4) ¿ 02 aug 2025.Batch size: 5,340 secondary packs ((b)(4) primary units).The complaint was received from finland reporting that the customer noticed foreign matter inside an unopened sterile dressing, suspected to be an insect.The complaint relates to material 1710656, batch 5g05063, manufactured on 25 jul 2025 and sterilized under sterigenics (b)(4) on 02 aug 2025.The issue impacted one (01) primary unit from (b)(4) secondary units ((b)(4) primary units).Three photographs were provided and confirm the presence of an insect within the dressing on one primary unit.No physical sample was received by our company.The complaint is confirmed based on the photographic evidence provided.A full batch record review was completed for lot 5g05063: all in-process checks, quality control inspections, and final release activities were acceptable.No material-, equipment-, or contamination-related issues were recorded.Good manufacturing practice (gmp) compliance records confirm appropriate gowning, environmental monitoring, and procedural adherence during the production period.No non-conformance was raised during production order (b)(4).No other complaints have been raised for batch 5g05063.Similar complaints: no other insect contamination complaints have been raised in the last 12 months for material code 1710656.Two insect contamination complaints (excluding (b)(4)) have been raised against the deeside site in the last 12 months: 2407075: raised oct 2025 from taiwan.Insect contamination found on a dressing upon opening, impacting one dressing for material 1713691 convatec foam lite 15×15 cm (1×10pk) ster eur.2309779: raised jul 2025 from poland.Insect contamination found on a dressing, impacting one dressing for aquacel foam ag adh 10×10 cm (sap 1705405, lot 5b02279).Corrective and preventive actions (capa) tw2341489, opened 12 aug 2025, is currently in the implementation phase and addresses the management of insect contamination, including evaluation of the number and placement of good manufacturing practice (gmp)-compliant insect light traps in production support areas (gowning lobbies and packaging corridors).The presence of an insect within the dressing does not impact batch traceability or labelling accuracy; however, it constitutes a foreign-body contamination that presents a potential biological risk to the patient and renders the product unusable, thereby impacting patient safety and product usability.As per process instruction (pi) ¿ general inspection (version 2.0), the required inspection level for labelling and contamination is acceptable quality level (aql) (b)(4), with accept at 5 / reject at 6 for batch sizes of (b)(4) primary units.For this batch, the appropriate inspection regime was applied during routine in-process and end-of-line checks.A total of 5,340 secondary units ((b)(4) primary units) have been sold, with stock exhausted across distribution centres.Across this population: no additional complaints or defect reports relating to contamination of either primary or secondary packaging, or similar visual anomalies, have been received.Quality monitoring, including batch record review, in-process inspection records, and device history checks, did not identify any trends or repeated occurrences.Based on the complaint rate (one contaminated primary unit reported from (b)(4) secondary packs / (b)(4) primary packs manufactured and sold), the batch remains well within acceptable quality level (aql) limits, and no acceptable quality level (aql) excursion has occurred.The observed defect rate (1 primary unit out of (b)(4) primary packs = (b)(4) percentage) remains below the notional (b)(4) acceptable quality level (aql) limit, confirming no evidence of an acceptable quality level (aql) excursion.Given the absence of repeat events for material 1710656, the absence of correlated deviations, and no similar complaints across distributed units, the risk to product quality and patient safety is assessed as minimal.The event appears isolated, with no evidence of a systemic failure mode.The most probable cause is environmental ingress of an insect into the cleanroom via gowning or packaging/warehouse airlock areas, combined with the absence of insectocutors in these transition zones.This represents a pest-control gap at the interfaces between controlled and uncontrolled areas.In cleanroom environments, pest control relies on prevention of ingress, environmental barriers, strict gowning and material transfer discipline, and passive monitoring traps in transition zones rather than active insect ¿zappers¿ within classified areas.The insect was found between the silicone adhesive and backing layer of the dressing.This indicates that the contaminant was introduced during the marrying of these two materials on the delta 1 line, after individual components had entered the cleanroom.Contributing factors.Pest-control design at transition points.Line design and product orientation: dressings exit delta 1 with the pink pu side facing upwards and are placed into crates in the same orientation.Operators therefore do not have routine visibility of both sides of the dressing during in-process checks.Reliance on manual visual inspection: there is no automated vision system implemented on delta 1 to verify dressing compliance.Inspection at this stage is entirely manual, and while operators perform visual checks during processing and of the finished primary pack prior to secondary packaging, the inspection method is inherently limited and cannot reliably detect all low-probability, small foreign-body defects.Summary: this was an isolated foreign-body contamination event introduced during processing on the delta 1 line.Batch traceability and labelling were not affected; however, the defect represents a potential biological risk and renders the impacted dressing unsuitable for use.The most probable cause was environmental ingress of an insect through cleanroom transition areas, compounded by the absence of insectocutors in gowning and material airlocks and the limitations of manual visual inspection on the delta 1 line.No additional units from the batch exhibited similar defects, and all available evidence supports this being a single-unit occurrence.The optima and delta lines are scheduled for upgrades and implementation of vision systems in 2026, such that both lines will be equipped with functioning vision and print-presence detection systems.This planned upgrade will address the core detection limitations that contributed to this event.With only one unit affected, the batch remains within specification and acceptable quality limits.The issue is considered isolated, with no systemic recurrence identified.No new corrective and preventive actions (capa) is required, as corrective and preventive actions (capa) 2341489 (opened 12 aug 2025) remains in implementation for insect contamination management, including review of insect light trap placement, updates to rentokil facility maps, and installation of additional good manufacturing practice (gmp)-compliant glue-board traps at cleanroom transition points.The complaint will be monitored through routine trending and 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: 9618003.

• 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: 24092123
• Report Number: 1000317571-2026-00010
• Device Sequence Number: 10239337
• Product Code: NAC
• UDI-Device Identifier: 00768455136650
• UDI-Public: 00768455136650
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: Lay User/Patient
• Device Model Number: 421151
• Device Lot Number: 5G05063
• Was Device Available for Evaluation?: No
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2025
• 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