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

Model Number	420621
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
Device 3 of 3 e1: complainant street address: (b)(6) complainant country: taiwan, province of china 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
The distributor reported that during inbound inspection foreign body was found within the primary pack.The product was not 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: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary: complaint : foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc).Region: tawian product / system application product (sap): 1703941 aquacel foam adh 17.5x17.5cm (1x10pk) nai lot: 5c05191.Date of manufacture: 30mar2025.Complaint reference: record in database.Sterilisation: sterigenics (b)(4) 06apr2025.Batch size: (b)(4).Record in database was received from the tawian reporting inbound inspection ¿ spots with different colour 3 impacted dressings.For material 1703941, lot 5c05191, the lot was manufactured on 30mar2025and sterilised under sterigenics (b)(4) on 06apr2025.The complaint indicates 03 primary units impacted from a batch size of (b)(4).One photograph was provided by the complainant to demonstrate the reported marks/contamination on 3 primary packs.The image was not clear and was low resolution.It was difficult to identify and confirm if contamination was present.No physical samples were returned to convatec for evaluation.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 was restricted, and a definitive root cause cannot be fully established.The assessment was therefore based solely on the limited photographic evidence available.A full batch record review was completed for lot 5c05191.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 corrective and preventive actions (capa) were raised during or for production order (b)(6), and no process deviations or non-conformances concerning contamination were identified in relation to lot 5c05191.No additional complaints has been assigned to batch 5c05191.A broader material-level review for material 1703941 (aquacel foam adh 17.5x17.5cm (1x10pk) nai) identified two further complaint for contamination over the past 12 months: records in database ¿ neither complaint had a related malfunction to record in database the circle line involves manual placement of exposed dressings onto the primary paper webpath and manual visual inspection prior to sealing.Visual inspection was performed while the line was in motion.Due to the small size and low contrast nature of the potential contamination (approximately 0.1 mm width), detection can be challenging for operators at standard inspection distance during dynamic processing.However, no deviations in inspection practice or procedure were identified during batch review.The current complaint relates to three primary packs reported with contamination.The total batch size was (b)(4).Of these, (b)(4) secondary units were distributed from distribution centres, with one additional feedback of similar issue, and (b)(4) remain in distribution center (dc) inventory without reported defects.Given the low occurrence rate (3 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.There was no evidence of correlated deviations, common defect signatures, or recurring contamination mechanisms.Both complaints involve isolated findings with no identified link to a shared root cause.As per process instruction (pi) general inspection, the required inspection level for contamination for a batch of this size was acceptable quality level (aql) 0.40, the appropriate inspection regime was applied at manufacture through routine in-process and end-of-line checks, and the acceptable quality level (aql) sample taken did not exceed the rejection threshold.Across the full manufactured population of (b)(4) secondary packs ((b)(4) primary units) no additional contamination-related complaint has been received for the batch.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 ((b)(4) primary units out of (b)(4) packs 0.014 percent remains below the notional 0.40 percent acceptable quality level (aql) limit, confirming no evidence of an acceptable quality level (aql) excursion.Due to the limited evidence available, the exact contamination mechanism cannot be conclusively determined.The marks observed in the image are consistent with several plausible sources of contamination, including: incidental transfer of ink or pigment from pens, markers, or operator handling deposition of small airborne or process-generated particulates prior to packaging localised residue transfer from equipment surfaces contamination introduced during distribution or customer handling contamination embedded within the foam layer originating from upstream foam manufacture visual inspection on the circle line was performed while the line was in motion by operators.Due to the small size and low contrast nature of contamination, detection can be challenging at standard inspection distances during dynamic processing.However, no deviations in inspection practice or procedure were identified during batch review.The circle line was currently scheduled for retirement, with a transition planned to a more automated manufacturing system.The future process will reduce manual handling of exposed dressings and incorporate enhanced inspection controls.This transition forms part of a planned continuous improvement initiative and was not related to the current complaint investigation.Based on the available information, the batch remains within specification and acceptable quality limits.The issue was considered isolated, with no indication of systemic manufacturing failure or recurring contamination mechanism.Based on work instructions (wi) risk assessment criteria, the event does not represent an increased risk to patient safety, device performance, or regulatory compliance.In alignment with work instructions (wi), there was no evidence of a systemic failure mode, recurring defect signature, or risk escalation that would necessitate corrective and preventive actions (capa).Therefore, corrective and preventive actions (capa) was not required, and the complaint will continue to be monitored through routine post-market product monitoring and trend review processes.The complaint will continue to be monitored through routine complaint 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: courtney smith ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24399166
• Report Number: 1000317571-2026-00027
• Device Sequence Number: 10113260
• Product Code: NAC
• UDI-Device Identifier: 00768455123728
• UDI-Public: 00768455123728
• 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): 01/27/2026

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: Other
• Device Model Number: 420621
• Device Lot Number: 5C05191
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2025
• 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