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

Model Number	420637
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foreign matter (dirt) found on dressing in two packets.The product was not used on patient.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Device 2 of 2.E1: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Samples are available for evaluation; however, shipping is in progress.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.
Event or Problem Description
To date, additional patient or event details were received which have been added in h10 (addl mfg narrative).
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well fda registration number: reporting site: 1049092.Manufacturing site: 1000317571.
Additional 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 state sample quality checks were satisfactory.Aquacel foam n/adh 15x20(1x5) nai was manufactured under system application product (sap) code (b)(4) and manufacturing lot number 2k01141 on 14 october 2022.Lot # 2k01141 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 2k01141.This is the first complaint for the affected lot registered within database, with a second for squashed and wrinkles dressing which is considered to be unrelated.Three (3) 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 flaky substance is seen on the edge of the pink polyurethane (pu) of the dressing.The complaint sample was requested, on 04 dec 2023 and received on 11 dec 2023.The soiled sample was received and sent to the lab for fourier transform infrared spectroscopy (ftir) analysis to identify that the foreign matter is a type of lubricant mixed with hydrofibre fibers.The contamination is most likely caused by hydrofibre deposition into lubricated, moving machine parts, which is then picked up by the dressing brushing past.This has been previously identified in complaint for which nc (non-conformance) record was opened.This is also related to corrective action / preventive actions (capa) which had action relating to clean to inspect, lubricate and tighten (cilt) standards being added to the process instruction (pi) document for the process.This capa is still in progress going through effectiveness checks, so no new capa is raised for this complaint as the previous will be covering this batch within bounding as the product was manufactured before improvement shave been made.Dressings are also inspected by human operators at speed, so it is possible for some defects to be missed.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.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: AQUACEL FOAM
• Common Device Name: 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: 18417242
• Report Number: 1000317571-2023-00332
• Device Sequence Number: 8145621
• Product Code: NAC
• UDI-Device Identifier: 00768455123865
• UDI-Public: 00768455123865
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2023

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
• Operator of Device: Other
• Device Model Number: 420637
• Device Lot Number: 2K01141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/18/2024; 02/22/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 02/09/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown