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

Model Number	420619
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	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the distributor that there four pieces dressings with colored dot.The product was not used by patient.The photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Device 2 of 4.E1: complainant street address: (b)(6) complainant country: philippines name of affiliation: (b)(6), complainant country: philippines, name of affiliation: (b)(6) philippines.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.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H11: investigation summary - complaint: foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc).Region: philippines product / system application product (sap): (b)(4) aquacel foam adh 12.5x12.5 (1x10pk) nai.Lot: 4l01554.Date of manufacture: 08 nov 2024.Sterilization: sterigenics wo3661594 22 nov 2024.Batch size: 5760 secondary packs (57600 primary units).This complaint was received from philippines reporting; distributor has reported 4 pieces dressing with coloured dot for material: 1703936 batch 4l01554.The lot was manufactured on 08 nov 2024 and sterilized under sterigenics wo(b)(4) 22 nov 2024.04 primary units impacted from (b)(4) secondary units ((b)(4) primary).5 photographs provided by the complainant to demonstrate the reported marks/contamination on 4 primary packs.The image shows dark surface marks on the pink polyurethane film (pu) side of the foam dressing.No physical sample has been received.The complaint has a valid lot number and has therefore been processed as a reportable complaint with no physical sample, in accordance with work instructions (wi).Should a sample be received, the complaint investigation will be re-opened and evaluated accordingly.The complaint is confirmed based on the photographic evidence supplied.The absence of a physical sample further restricts the ability to conduct a detailed hands-on examination.The absence of returned product limits the ability to perform a detailed, hands-on assessment of the defect.Without higher-resolution images or physical samples, the depth of investigation is restricted, and a definitive root cause cannot be fully established.The assessment is therefore based solely on the limited photographic evidence available.A full batch record review was completed for lot 4l01554.¿ all quality control (qc) inspections and final release activities were recorded as acceptable.¿ no material-related or contamination-related issues were documented.¿ good manufacturing practice (gmp) compliance records confirm appropriate gowning, environmental monitoring, and adherence to defined procedures during the production period.No non-conformance raised during the production order.A batch-specific trend review was performed for batch 4l01554.No additional complaints have been identified for this batch.There is no evidence of batch-specific recurrence or clustering of similar defects.A material-level trend review was conducted for aquacel foam adh 12.5 × 12.5 cm (1 × 10pk), nai covering the last 24 months.Two additional complaints with the same malfunction (foreign matter within product, sterile products) were identified: ¿ complaint ¿ batch 4e04259, raised 12-mar-2025 two dressings reported with coloured dots on the dressing surface.The contamination was identified on the pink pu layer and attributed to supplier-introduced contamination.¿ complaint ¿ batch 3j02327, raised 30-sep-2024 one dressing reported with coloured dots on the dressing surface.The contamination was identified on the pink pu layer and attributed to supplier-introduced contamination.Although these complaints share the same malfunction, they relate to supplier-origin contamination of the foam raw material, whereas the current complaint involves dark surface marks of undetermined origin.No common contamination mechanism or manufacturing linkage has been identified the current complaint relates to four primary pack reported with contamination.The total batch size was (b)(4) secondary units (equivalent to 57600 primary units).Of these, (b)(4) secondary units were distributed from distribution centres, with no additional feedback of similar issues, and (b)(4) units remain in dc inventory without reported defects.Given the low occurrence rate (04 reported events out of (b)(4) distributed secondary units - (b)(4) primary units), the complaint frequency remains low relative to the total distributed quantity.The available evidence does not suggest a systemic or batch-wide manufacturing issue.No other complaints have been raised for this batch.The reported contamination involves four primary units within a single complaint, with no evidence of recurrence or clustering.Both trended complaints involve isolated, single-unit findings with no identified link to a shared root cause.No additional similar complaints have been identified across distributed units.Based on the combined data set, the risk to product quality and patient safety remains minimal, and the events appear limited in scope with no indication of a systemic failure mode.As per process instruction (pi) ¿ general inspection, the required inspection level for contamination for a batch of this size is acceptable quality level (aql) 0.40, using an accept = 5 / reject = 6 sampling plan for a sample size of (b)(4) units.The appropriate inspection regime was applied at manufacture through routine in-process and end-of-line checks.The aql sample taken did not exceed the rejection threshold.Across the full manufactured population of (b)(4) secondary packs ((b)(4) primary units): ¿ batch record review, in-process inspections, and device history checks identified no deviations, no recurring issues, and no process-related trends.¿ the observed defect rate (04 primary units out of (b)(4) primary packs = (b)(4)) remains below the notional (b)(4) aql limit, supporting that manufacturing inspection results remained within established acceptance criteria, with no indication of loss of process control no additional similar complaints have been identified across distributed units.Based on the combined data set, the risk to product quality and patient safety remains minimal, and the events appear limited in scope with no indication of a systemic failure mode.Based on work instructions (wi) risk assessment criteria, the event does not represent increased risk to patient safety, device performance, or regulatory compliance.In alignment with work instructions (wi), there is no evidence of a systemic failure mode, recurring defect signature, or risk escalation that would necessitate corrective and preventive actions (capa).Therefore, capa is not required, and the complaint will continue to be monitored through routine post-market product monitoring and trend review processes.As photographs were provided and no physical sample was returned, the contamination mechanism cannot be conclusively determined.The dark spot observed in the images was consistent with several plausible sources of contamination, including: ¿ incidental transfer of pigmented material consistent with ink or dye-type contamination ¿ deposition of small airborne or process-generated particulates prior to packaging.¿ localised residue transfer from equipment surfaces; or introduction of foreign material post-manufacture during distribution or customer handling.¿ contamination present within subcomponent materials as received from external suppliers due to the limited evidence available, no single root cause can be confirmed.The dressings are inspected by operators, but as the foreign matter was of such a small size (approximately 0.10mm on the tappi chart indicated), this foreign matter may not have been readily detectable at validated inspection speeds previous complaints resulted in a historical capa and formal investigation to assess potential sources of contamination during the manufacture of dressings.That investigation concluded that the contamination originated from the foam raw material, which became contaminated during the supplier¿s processing activities.The findings and corrective actions from formal investigation were reviewed for applicability to the current complaint.No evidence was identified to indicate recurrence of the same contamination mechanism, and the affected batch (4l01554) was manufactured after implementation of the corrective actions associated with formal investigation.There is no indication that the historical issue represents a related item or contributes to the current event.The batch remains within specification and acceptable quality limits.The issue is considered isolated, with no systemic recurrence identified.No capa is required.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: 1000317571.
Event or Problem Description
To date no additional patient or event details have been received.

• 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: 23377622
• Report Number: 1000317571-2025-00127
• Device Sequence Number: 8864023
• Product Code: NAC
• UDI-Device Identifier: 00768455123711
• UDI-Public: 00768455123711
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: 420619
• Device Lot Number: 4L01554
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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