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

Model Number 187930

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

It was reported that there were water droplets on the surface of the inner tube.The product was not used on the patient.Photographs depicting the issue were received from the complainant.

Event Description

It was reported that there were water droplets on the surface of the inner tube.The product was not used on the patient.Photographs depicting the issue were received from the complainant.

Event Description

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

Manufacturer Narrative

Duoderm paste (1tubex30g) was manufactured under sap code 1000894 and manufacturing lot number 0a01790 on 30 jan 2020.Lot # 0a01790 was sterilised under reference (b)(4) and released on review of results of sterilisation provided by sterilisation company steris.All the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 0a01790.This is the third complaint for the affected lot registered within tw (b)(4).The two other complaints are related to stained market boxes (b)(4).The complaint issue shown is associated with the issue in nonconformance tw (b)(4) and previous complaints received for greasy tubes and stained boxes.No additional investigation was required as the complaint issues has occurred previously and the reason is understood.What was described as water droplets in the complaint intake is most likely propylene glycol, which is a viscous, colourless liquid.This is an oily substance to touch and is also most likely the cause of the stained market boxes, as it is known to get trapped in the tube crimp and leak out.It is unlikely the substance is water, as while sterilisation (steaming) would have introduced water, this is unlikely to still be on the surface of the tubes 2 years after manufacture unless other local environmental conditions had introduced condensation.24 photographs were received for this issue and have been evaluated in accordance with wi-0359.The photographs confirm the expected lot number, product and the complaint issue where droplets of liquid can be seen on the surface of a tube.The liquid is not, however, water.4 photographs supplied by the complainant show tertiary packaging bearing a label stating the contents as batch 9b03392.It is questioned if this box has been repackaged and relabeled and when this occurred.If the boxes have been removed and relabeled, there is no guarantee that they have been placed back into the cartons in the same orientation that they should be.It is questioned if the boxes were discoloured and greasy at the time of relabeling, or if this has occurred after relabeling.This paste product has since been discontinued.No further action is required or possible due to the manufacturing line having 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: 13565500
• MDR Text Key: 286000675
• Report Number: 1000317571-2022-00024
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187930
• Device Lot Number: 0A01790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/21/2023
• Date Device Manufactured: 01/30/2020
• 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