MAUDE Adverse Event Report: CONVATEC LTD L3W0600 - AQUACEL; DRESSING,WOUND,HYDROPHILIC

Model Number 420673

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant street address: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review indicates no discrepancies.Pm logs were checked and no discrepancies were found.Affected amount: 1pc.Aquacel extra 15x15cm was manufactured under sap code 1704595 and manufacturing lot number 0c03261.Lot # 0c03261 was sterilized under lot 1242009911 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 pi12-158 ver.4.0 for machine pmk.Visual inspection in accordance with tm-002 was completed at the beginning of the order and every hour following until the order was completed.No nonconformity was registered during the manufacturing process of lot 0c03261.This is the only complaint for the affected lot registered within tw8.7.A photograph has been received for this issue and has been evaluated in accordance with wi-0359.The photograph confirms the batch number, the expected product and complaint issue.The photograph shows a black spot on the dressing.No physical sample is being returned therefore it cannot be determined what the black spot is.Operations have been informed of the complaint issue.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.(b)(4).

Event Description

It was reported that there was a black spot found on the device.The product was not used on patient.A photograph depicting the issue was received from the complainant.

• Brand Name: L3W0600 - AQUACEL
• 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 10934911
• MDR Text Key: 240638286
• Report Number: 1000317571-2020-00163
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 420673
• Device Lot Number: 0C03261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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