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); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by distributor that they found dents and tube perforation as depicted in the photo in primary package material.The product was not used on patient.A photograph depicting the issue was received from complainant.
Additional Manufacturer Narrative
E1: complainant street address: (b)(6) complainant city: kulai complainant state: johor complainant postal code: (b)(6) complainant country: malaysia complainant phone: (b)(6) 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: (b)(4) manufacturing site: (b)(4).
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: 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 (b)(4) and manufacturing lot number 3f04491 on(b)(6) 2023.System application product (sap) states the manufacture date as (b)(6), but the batch record confirms manufacturing began on (b)(6) 2023.Lot # 3f04491 was sterilized under (b)(6) batch ssp120623-1-1 and released on review of results of sterilization provided by sterilization company andersen caledonia.All the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 3f04491.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 front of the tube exhibits a curved imperfection in the white lacquer.The imperfection is discolored orange and looks similar to rust, but this is the discoloration of the lacquer as the tube is made from aluminum.There is no evidence to confirm the imperfection is a perforation in the tube, as no gel can be seen coming from the imperfection.If it was an actual hole in the tube wall, it is likely that wet and dried gel would be evident.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 ((b)(4)) was supplied from supplier (b)(4).Ordinarily, a scar (supplier corrective action report) would be raised for supplier (b)(4), but (b)(4) 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.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 is being 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 imperfection may not have been immediately observable at the point of packing as the discoloration may have been influenced by the sterilization process and therefore deteriorated afterwards.It is possible that the imperfection was missed at the point of packing.As the packaging is not damaged it is unlikely for the damage to have been sustained during transit.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.

• 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 ; 3365424679
• MDR Report Key: 18765819
• Report Number: 1000317571-2024-00011
• Device Sequence Number: 4500148
• 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): 01/29/2024

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: 06/01/2026
• Device Model Number: 187987
• Device Lot Number: 3F04491
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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