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

Model Number 420636

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

Device 3 of 3.Complainant city: (b)(6).Event country: germany.Name of affiliation: (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).Manufacturing site: (b)(4).

Event Description

It was reported that there was foreign matter (black dirt) and it was soiled.The product was not used by the patient.The photographs depicting the issue were received from the complainant.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary: a batch record review was completed, and no discrepancies were found.All in-process stat sample quality checks were satisfactory.Aquacel foam n/adh 20x20(1x5) eur was manufactured under system application product (sap) code 1703999 and manufacturing lot number 2e03439 on 24 may 2022.Lot # 2e03439 was sterilized under work order (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 2e03439.This is the only complaint for the affected lot registered within database.5 photographs were received for this issue and has been evaluated in accordance with work instruction (wi).The photograph confirms the expected product and the complaint issue where foreign matter in the form of a black substance are seen on the pink pu (polyurethane) of the dressing.The complaint sample was requested but was unavailable, so it is not possible to confirm what the foreign matter is.An nc (non-conformance) was opened for this issue for foreign matter on the dressing.It was not possible to obtain the complaint sample, but examining the photographs, the foreign matter appears to be a grease of some kind.As the product was placed on stop ship, the stopped stock was requested to be returned to deeside in an effort to identify the black contamination.Product was returned from spain and italy and inspected to identify black marks on the edge of 3 dressings from the remaining product.Investigation concluded the contamination was most likely caused by hydrofibre deposition into lubricated, moving machine parts, which is then picked up by the dressing brushing past.A further correction has been requested to check if rotating machine parts within the manufacturing line can be closed off to improve the cleanability of the machine.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: (b)(4).

Event Description

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

• Brand Name: 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: 16120112
• MDR Text Key: 308647513
• Report Number: 1000317571-2023-00018
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 420636
• Device Lot Number: 2E03439
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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