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); Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385); 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 street address: (b)(6).Complainant city: (b)(6).Complainant state: (b)(6).Complainant postal code: (b)(6).Complainant phone: +(b)(6).Complainant country: taiwan, province of china.Based on the available information, this event is deemed to be a reportable malfunction.A batch record review was completed and no discrepancies were found.Duoderm h/active gel (3tbex30g) ster us was manufactured under system application product (sap) code 1002859 and manufacturing lot number 2e03233 on 24 may 2022.System application product (sap) identifies 25 may 2022 as the manufacture date, but the batch record confirms the batch began late on 24 may 2022.Lot # 2e03233 was sterilized under baxter g.R.No (b)(4) and released on review of results of sterilization provided by sterilization company baxter.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 2e03233.This is the only complaint for the affected lot registered within database.One photograph was received for this issue and has been evaluated in accordance with work instructions (wi).The photograph confirms the product and the complaint issue where the shoulder of the tube is deformed, and a perforation can be seen.The product lot cannot be seen in the image.There is evidence of dried and discolored gel on the tube shoulder at the point of the perforation.It is noted a large label is applied to the back of the tube.A nonconformance was not opened for this complaint issue.As per procedure, acceptance quality limit (aql) is identified as 4.0 for primary pack appearance or 0.65 for contamination.As the batch size is (b)(4) primary units, a single primary pack affected by the contamination aspect would be acceptable in a sample of (b)(4) units.No further complaints have been received against this batch.The aluminum tubes used in this batch would have been provided by supplier (b)(4).As it is unlikely that the tube could have been in this condition before filling, contacting the supplier would not be necessary.The supplier has since ceased trading, so would not be possible anyway.It is likely this imperfection would have been observable at the point of packing, so is unlikely to have been packed.It is possible to have been caused at the point of packing.There is no comment from the complainant as to the condition of the secondary pack.The local distribution quality team were asked for comment, as a large label is seen applied to the gel tube.It is confirmed that the product has been relabeled locally, and no non conformance was identified.This suggests the tube was intact at the point of relabeling, ruling out the manufacturing site.It was noted the product was shipped between different retailer stores.Without knowing the condition of the secondary pack, it is not possible to identify if the damage was sustained while being repacked following local labelling.Damage is most likely to have been sustained in transit between the different retailer stores.This issue will be monitored through the post market product monitoring review process.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 retailer reported that the gel tube was split, rusted and gel was lost.The product was not used.A photograph depicting the issue was received from the complainant.

• 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: 19340939
• Report Number: 1000317571-2024-00040
• Device Sequence Number: 17927793
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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 Expiration Date: 05/01/2025
• Device Model Number: 187987
• Device Lot Number: 2E03233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2022
• 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