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

Model Number	420635
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Name of retailer: medfirst.Complainant street address: (b)(6).Complainant city: (b)(6).Complainant state/province: (b)(6).Complainant postal code: (b)(6).Complainant phone number:(b)(6).Complainant 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.Fda registration number (b)(4).
Event or Problem Description
It was reported that hairs were found inside the primary packaging.The product was not used by patient.The photographs depicting the issue were received from the complainant.
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.A batch record review was completed and no discrepancies were found.All in-process stat sample quality checks were satisfactory.Aquacel foam n/adh 15x15(1x5) nai was manufactured under system application product (sap) code 1703996 and manufacturing lot number 1c00248 on 03 march 2021.Lot # 1c00248 was sterilised under order identification 2841865 and released on review of results of sterilisation provided by sterilisation company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 1c00248.This is the only complaint for the affected lot registered within database.3 photographs were received for this issue and has been evaluated in accordance with work instruction (wi).The photograph confirmed the expected product and the complaint issue where foreign matter (hair) can be seen on within the primary pack.A nonconformity(nc) was opened for this issue for foreign matter on the dressing.An investigation was raised and identified that the root cause was personnel, as the foreign matter was a human hair.A corrective/preventative action (capa) was raised to cover corrective and preventative actions for retraining of personnel in manufacturing for good manufacturing practice (gmp), awareness training for bulk packing and microbiology training for manufacturing shifts.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: 15585667
• Report Number: 1000317571-2022-00328
• Device Sequence Number: 17927554
• Product Code: NAC
• UDI-Device Identifier: 00768455123841
• UDI-Public: 00768455123841
• 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
• Report Date (Section B): 09/19/2022

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 Expiration Date: 03/01/2026
• Device Model Number: 420635
• Device Catalogue Number: 420635
• Device Lot Number: 1C00248
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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