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); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the distributor that there was a foreign body in gel when squeeze out for using gel.However, the product was not used by patient.The photographs depicting the issue were received from the complainant.
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.
Additional Manufacturer Narrative
Correction: h4: device manufacture date - in initial emdr, the manufacture date was added as 23 august 2023, but the batch record confirms the manufacture date is 22 august 2023.Hence, it has been corrected.Additional information - this emdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H3: device evaluated by manufacturer? has been selected as yes h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary 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 3h00019 on 22 august 2023.System application product (sap) states the manufacture date as 23 august 2023, but the batch record confirms the manufacture began on 22 august 2023.Lot # 3h00019 was sterilized under andersen caledonia batch and released on review of results of sterilization provided by sterilization company andersen caledonia.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 3h00019.This is the only complaint for the affected lot registered within database.This is also the only complaint in database for this malfunction code identifying a foreign body within the gel.No other complaints have been received identifying foreign matter, so this is most likely an isolated issue.3 photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the expected lot number, product and the complaint issue where some gel is squeezed out onto a white material, showing small flake-like foreign matter that was yellow in colour.The complaint sample was requested on 07 oct 2024 and received on 31 oct 2024.A nonconformance was not opened for this complaint issue, as the aluminum tubes for the gel product is supplied by an external supplier.The supplied material (1024928g1) was supplied by supplier pharmatube.Ordinarily, a scar (supplier corrective action report) would be raised for supplier pharmatube, but pharmatube are no longer trading and are in administration.As such, the resolution of this issue with the supplier is not possible as they have ceased trading and would be unable to investigate, identify issues or resupply.The gel tube returned under complaint was evaluated, and a small amount of gel was squeezed from the opened tube.No foreign material was found.The tube was then cut open to check the entire remaining contents of the tube.All gel was removed and checked for foreign matter, with none found.The inside of the tube was inspected, with no missing areas in the lacquer coat.However, there was one area in the shoulder of the tube where the lacquer looked thicker and darker.There was no evidence of this lacquer becoming detached.As the colour of the foreign matter appears to match the colour of the lacquer inside the tube, it is most likely that the foreign matter is excess lacquer detached from the inside of the tube.The batch of gel tubes received from the supplier was identified as batch 1090640996, received on 06 feb 2023, so were not out of expiry for use.Similar issues relating to the quality of the gel tubes themselves are also not possible to be resolved.A new supplier for the gel tubes has been sourced and validated.As no further investigation is possible, the complaint investigation will be closed.Any further complaints received for the gel tubes that require supplier investigation will be unable to progress.This issue will be monitored through 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: 20555578
• Report Number: 1000317571-2024-00079
• Device Sequence Number: 13006693
• 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): 10/04/2024

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: 08/01/2026
• Device Model Number: 187987
• Device Lot Number: 3H00019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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