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

Model Number 177901

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

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device 12 of 18.Brand name: aquacel/ aquacel ag surgical cover dressing.Complainant city: (b)(6).Complainant state/province: (b)(6).Complainant phone: (b)(6).Patient country: (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.(b)(4).

Event Description

It was reported the product was caught in the seal.The product was not used.Photographs depicting the reported complaint issue were provided by the complainant.

Event Description

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

Manufacturer Narrative

A batch record review indicates no discrepancies.Pm logs have been checked and they were all completed with no discrepancies.Affected amount: 18pcs.Aquacel drs 5x5cm was manufactured under sap code: 1161262 and manufacturing lot number: 0f01132.Lot#: 0f01132 was sterilised under lot: 1244656811 and released on review of results of sterilisation provided by sterilisation company steris.All of the results were within specification and the products were released.The production process, in-process testing and packaging of products as run in accordance with pi12-027 ver.For machine doyen 3.Visual inspection in accordance with tm-002 was completed at the beginning of the order and every 15 minutes following until the order was completed.No nonconformities was registered during the manufacturing process of lot: 0f01132.There are 3 complaints for this lot within tw8.7 however are for different complaint issues.3 photographs have been received for this issue and have been evaluated in accordance with wi-0359.The photographs confirm the expected product and batch.They also confirm the expected complaint issue.The issue is caused by dressings catching on the vision system light box cover, bunching up and moving into the weld area.A ccr (ccr-dmr-00188) is currently being completed for a new vision system which will include a new light box and guard.This will eradicate the issue found within this complaint.Operations have been informed of the complaint issue.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 1000317571.

• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• MDR Report Key: 10715620
• MDR Text Key: 212527024
• Report Number: 1000317571-2020-00153
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 177901
• Device Lot Number: 0F01132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1