MAUDE Adverse Event Report: CONVATEC LTD L3W0650 - AQUACEL FOAM; Dressing, wound, hydrophilic

Model Number 422359

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

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

Event Type  malfunction  

Event Description

Based on the pictures received from the complainant, there were unsealed packages.The product was not used on patient.

Manufacturer Narrative

A batch record review was completed and no discrepancies were found.Affected amount: 2 devices aquacel foam pro 8x8 1x10pk nai was manufactured under sap code 1724193 and manufacturing lot number 1g02217 on 20 july 2021.Lot # 1g02217 was sterilised under id 2827175 and released on review of results of sterilisation provided by sterilisation company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 1g02217.This is the only complaint for the affected lot registered within tw- (b)(4).1 photograph was received for this issue and has been evaluated in accordance with wi-(b)(4).The photograph does not confirm the expected lot number, but the two devices under complaint are shown in aquacel foam pro primary packaging, where the top seals of the primary sachets are open and unsealed.A nonconformance was opened for this complaint issue tw-(b)(4) a data review tw-(b)(4) was completed , but as other complaints and non-conformance's had been raised for similar failures, an investigation was already completed tw- (b)(4) and a capa was already opened for this issue tw- (b)(4) capa 1481770 was raised to address findings from child investigation 1468263.Capa was closed on 07-jan-2022.Complaint batch 1g02217 (july-2021), manufactured prior to completion/closure of preventative action 1487809 and correction 1487810 within capa.Capa closed as ¿effective¿.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 1000317571.

• Brand Name: L3W0650 - AQUACEL FOAM
• Type of Device: Dressing, wound, hydrophilic
• 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: 13718843
• MDR Text Key: 289606755
• Report Number: 1000317571-2022-00067
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00768455157341
• UDI-Public: 00768455157341
• Combination Product (y/n): N
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 422359
• Device Lot Number: 1G02217
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/01/2023
• Date Device Manufactured: 07/20/2021
• 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