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

Model Number 420673

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

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Device 42 of 82.(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 is attached to the seam of the package.That makes the product nonsterile." the product was not used.Photographs depicting the reported complaint issue were provided by the complainant.

Manufacturer Narrative

A batch record review indicates no discrepancies.Pm logs have been checked and all pm's were completed with no discrepancies.Affected amount: 82 pcs.Aquacel extra 15x15cm was manufactured under sap code 1704596 and manufacturing lot number 0c01702.Lot # 0c01702 was sterilized under lot 1241802511 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 0c01702.This is the only complaint for the affected lot registered within tw8.7.3 photos have been received for this issue and have been evaluated in accordance with wi-0359.The photographs confirm the lot number, the expected product and confirm the complaint issue.Event 1408844 was raised with investigation 1409381.The investigation found that the sensor which detects the presence of product within top and bottom seals was positioned incorrectly during the production of lot 0c01702 and therefore did not detect the dressing within the seal area in the crosswise direction.The investigation is now completed and closed.No further action required.Operations have been made aware of the complaint issue and have been trained on the correct position of the sensors for each pack size.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 1000317571.

Event Description

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

• Brand Name: AQUACEL EXTRA
• 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: 10555674
• MDR Text Key: 207608266
• Report Number: 1000317571-2020-00092
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420673
• Device Lot Number: 0C01702
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1