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

Model Number 187930

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that there was container leakage which was evident prior to use.The tubes were not damaged and there was no visible cut or crack on primary package, but the secondary and primary packaging was greasy to touch.It was unknown if the product was used by the end user.Photographs depicting the issue were received from the complainant.

Manufacturer Narrative

Device 3 of 3.(b)(4).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.(b)(4).

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

A batch record review indicates no discrepancies.No nonconformity was registered during the manufacturing process of lot 0b02944.Granuflex h/colloid paste 30g was manufactured under sap code 1181514 and manufacturing lot number 0b02944.Lot # 0b02944 was sterilized under lot 2173-8209a and released on review of results of sterilization provided by sterilization company steris.All results were within specification and products were released.This batch has previously been reported under complaint.This is the fifth complaint received against batch 0b02944 (previous complaints: (b)(4) and is the third complaint for this batch and malfunction code (wnd-pmc09.06 primary pack (sterile products) has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging).One photograph has been received for this complaint and has been evaluated in accordance with wi-(b)(4).The photograph shows 3 secondary pack cartons which appear discoloured and yellowed.The product shown is the expected product, but the lot number is not displayed.No images of the primary pack are available, and therefore the part of the complaint pertaining to the greasy appearance of the primary pack cannot be confirmed.The issue reported has been seen before, and the yellowing of the secondary pack appears to be a result of excess paste within the crimp of the tube which has leaked onto the secondary carton giving it a yellow, greasy appearance.Duoderm paste has since been discontinued and the line has been removed from deeside.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 1000317571.

• Brand Name: L3W1275 - DUODERM PASTE AND GELS
• Type of Device: 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: 13106737
• MDR Text Key: 284988775
• Report Number: 1000317571-2021-00257
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 187930
• Device Lot Number: 0B02944
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1