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

Model Number 187930

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Manufacturer Narrative

Mdr 1000317571-2021-00168 / device 9 of 13.Complainant city: (b)(6) complainant phone: (b)(6) patient country: (b)(6).Contact office address: (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 Description

It was reported that the contents of an unknown number of tubes in the 13 boxes had leaked, which made all 13 boxes greasy and therefore unsellable.The products were not used.A photograph depicting the issue was received from the complainant.

Manufacturer Narrative

Correction (g1) -(b)(6).A batch record review indicates no discrepancies.Pm logs have been checked and all pm's have been completed with no discrepancies found.Affected amount: (b)(4).Duoderm paste 30g was manufactured under sap code 1000894 and manufacturing lot number 9m00772.Lot # 9m00772 was sterilized under lot 2173-7093a and released on review of results of sterilization provided by sterilization company steris.All of the results were within specification and products were released.The production process, in process testing and packaging of products was run in accordance with pi12-021 ver.25.0 for paste.Visual inspection in accordance with pr20-009 was completed at the beginning of the order and every hour following until the order was completed.No nonconformity was registered within the manufacturing process of lot 9m00772.This is the only complaint for the affected lot registered within tw8.7.2 photographs have been received for this issue and have been reviewed in accordance with wi-0359.The photographs confirm the product expected and the complaint issue.The issue appears to be excess paste within the crimp of the tube and has leaked onto the tube.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.

Event Description

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

• 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
• MDR Report Key: 11892926
• MDR Text Key: 260493845
• Report Number: 1000317571-2021-00168
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187930
• Device Lot Number: 9M00772
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1