MAUDE Adverse Event Report: CONVATEC LTD DUODERM PASTE AND GELS; DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC

Model Number	187987
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (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 was a broken seal on one unit of company's known gel tube.The box was intact.The product was not used by patient.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 was received from malaysia reporting one unit of duoderm h/active gel (3tbex30g) with a broken seal.The affected lot was 4k00378 (system application product (sap) 1002859), manufactured on 27 nov 2024 and sterilized by (b)(4) under cycles (b)(4) (completed 15 oct 2024).Batch size: (b)(4) secondary packs ((b)(4) primary).Sterilization was performed prior to final packing.One photograph was provided and reviewed in accordance with work instructions (wi).The product and lot number were confirmed.The image shows the tube with the collar still present.For this configuration, the collar must be removed before the cap can be tightened and the foil seal broken.The presence of the collar therefore demonstrates that the seal was intact at manufacture.This indicates that subsequent tampering may have occurred post-distribution.No physical sample was returned.A full batch record review was completed for lot 4k00378.All in-process checks, stat sample inspections, and final quality checks were found satisfactory.No deviations, rework, or non-conformances were raised.Sterilization results met specification and were released by anderson caledonia.A review of the tube and cap pre-assembly and fill process confirmed that multiple operator and automated checks are in place: ¿ supplier: on receipt of tube + collar + cap assemblies.¿ at cap-tightening, where operators verify collar presence and correct engagement.¿ second operator check for cap height/fit before transport.¿convatec gel fill: operators confirm collar/cap before filling, tubes pass cap-tightening station and upside-down detector, followed by in-line check weigh.¿ post-fill: operators check for leaks before packing into corex boxes.¿ sterilization: pre- and post-checks confirm no damaged caps, leaks, or burst tubes.Any compromised seal would have failed sterilization due to high temperature/pressure.¿ convatec secondary packaging at deeside: manual hand-pack with operator visual checks, in-process quality assurance (qa) checks, and final inspection (count, labels, expiry, inserts, contamination, shipper integrity).Trend review: no other complaints have been recorded for lot 4k00378.One unrelated complaint was reported on a different lot where an open tube was observed after the collar had been removed, indicating post-distribution tampering.Another complaint was raised for batch 4g00418.Where an open tube was observed with the collar intact on the tube.Indicating post-distribution tampering complaint originated from malaysia no trend across lots was evident.Risk assessment: confirmed issue but not attributed to deeside.Collar still present, indicating seal was intact through manufacture and sterilization.No deviations recorded; sterilization would have identified compromised seals.The most likely root cause was tampering or damage during handling at the distribution center or post-distribution.According to process instruction (pi), the acceptable quality level (aql) for primary pack seal integrity was 0.40 (accept at 1, reject at 2 for 125).At manufacture, lot 4k00378 was inspected against this plan and accepted.Post-distribution, one unit from 8820 has been reported, which does not represent an acceptable quality level (aql) excursion.Conclusion: this was an isolated occurrence with no impact to other units.No systemic issue was identified at deeside.The issue was most consistent with distribution-level tampering.In accordance with work instructions (wi), corrective action / preventive actions (capa) was not 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: DUODERM PASTE AND GELS
• Common Device Name: DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC
• 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: 22910872
• Report Number: 1000317571-2025-00089
• Device Sequence Number: 15758433
• Product Code: NAE
• UDI-Device Identifier: 00768455172979
• UDI-Public: 00768455172979
• 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): 08/03/2025

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: Lay User/Patient
• Device Model Number: 187987
• Device Lot Number: 4K00378
• 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: 08/03/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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