MAUDE Adverse Event Report: CONVATEC LTD AQUACEL AG FOAM; DRESSING, WOUND, DRUG

Model Number 420681

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported by retailer about identification of visual contamination in the form of brown spots present on every dressing.The product was not used.The photographs and video were received from the complainant.

Manufacturer Narrative

Device 10 of 18.Initial reporter name and 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).

Event Description

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

Manufacturer Narrative

A batch record review was completed, and no discrepancies were found.Aquacel foam ag adh 10x10cm 1x10pk nai was manufactured under system application product (sap) code (b)(4) and manufacturing lot number 2c03689 on 28 march 2022.Lot # 2c03689 was sterilized under work order 3098806 and released on review of results of sterilization provided by sterilization company sterigenics.All the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 2c03689.Two photographs and a video were received for this issue and has been evaluated in accordance with work instruction (wis).The photographs confirm the expected lot number, product, and complaint issue, where yellow-brown diffused spots can be seen on the dressing pad at the point of intersection of the silicone border and the release liner fold.The video shows a primary sachet being opened to reveal brown spots on the dressing inside.The samples under complaint were requested for investigation on 01 december 2022 and received on 16th december 2022.A nonconformance was opened for a previous complaint received with an identical failure mode.The nonconformance now covers four (04) complaints against four (04) different batches for the same failure mode.Root cause analysis has identified the brown spots were caused by lubricant transfer from the kiss cut tool during conversion process on delta one (01) manufacturing line.Sample analysis identified this is a mix of lubricant spray and isopropyl alcohol (ipa) cleaner, although it has not been possible to replicate the issue.Several root causes and contributing root causes were identified, and corrective and preventive actions (capa) has been opened to address improvements to prevent recurrence.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: 1049092, manufacturing site: 1000317571.

• Brand Name: AQUACEL AG FOAM
• Type of Device: DRESSING, WOUND, DRUG
• 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: 16032143
• MDR Text Key: 308385813
• Report Number: 1000317571-2022-00376
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: K123481
• 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: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/01/2024
• Device Model Number: 420681
• Device Lot Number: 2C03689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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