MAUDE Adverse Event Report: CONVATEC LTD L3W1275 - DUODERM PASTE AND GELS; NOT APPLICABLE

Model Number	187987
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
Common device name - dressing,wound,hydrogel w/out drug and/or biologic.Complainant city: (b)(6).Complainant state: (b)(6).Name of affiliation: (b)(6).Complainant country: (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: (b)(4).Manufacturing site: (b)(4).
Event or Problem Description
It was reported that the gel tube had a stain, apparently it was rust.The product was not used by customer.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Duoderm h/active gel (3tbex30g) ster us was manufactured under sap code (b)(4) and manufacturing lot number 1l00201 on 28 november 2021.Lot # 1l00201 was sterilised under reference 21k15k6161 and 21k15k6161 and released on review of results of sterilisation provided by sterilisation company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 1l00201.This is the only complaint for the affected lot registered within trackwise.2 photographs were received for this issue and have been evaluated in accordance with (b)(4).The photographs confirm the expected lot number, product and the complaint issue where a small indent in the gel tube can be seen.While the gel tube under complaint was requested for investigation, it was not possible to have the sample returned due to courier restrictions in the latam region for the product.A nonconformance was opened for this complaint issue (b)(4).Triage identified that the photographs received showed the tube to have printed information not applied at the manufacturing site.Latam regulatory representatives confirmed this relabelling activity is completed in caribetrans latam warehouses due to local requirements using an inkjet printer.The process was recently audited by latam regulatory representatives, and they confirm the inkjet printer has no sharp parts that could indent the metal tube during printing.They comment that the process for the tubes to be relabelled is a manual process where all units would be checked prior to receiving the additional labels, so it is expected that the damage would have been identified at this point had it been present, but is not guaranteed.It is therefore still possible that the indent could have occurred at the manufacturing site or was present on the tube when received from the supplier, but it is not possible to confirm exactly where the indent occurred.The indent reported for this single device is an isolated issue, and no further investigation is possible as the product was not received for investigation.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: L3W1275 - DUODERM PASTE AND GELS
• Common Device Name: NOT APPLICABLE
• 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 ; 3365424679
• MDR Report Key: 14495237
• Report Number: 1000317571-2022-00074
• Device Sequence Number: 20232563
• 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,Followup
• Report Date (Section B): 04/27/2022

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: 11/01/2024
• Device Model Number: 187987
• Device Lot Number: 1L00201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2021
• 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