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

Model Number	413568
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the nurse that black, hard spots were noticed for a dressing when it was taken out of the packaging of five.Customer confirmed that the package was sealed upon receipt.The dressing was not available to send back as the complainant had sent it to an independent testing facility (surgical materials testing laboratory - smtl) for testing.The product was not used on the patient.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review was completed, and no discrepancies were found.All in-process stat sample quality checks were satisfactory.The sample within the batch record was checked for hard matter, but none was identified.Aquacel ag+ extra 15x15cm(1x5pk) ster eur was manufactured under system application product (sap) code 1708334 and manufacturing lot number 3d04407 on 02 may 2023.Lot # 3d04407 was sterilized under reference id 2163-3519a and released on review of results of sterilization provided by sterilization company steris.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 3d04407.This is the only complaint for the affected lot registered within database.One photograph was received for this issue so could be evaluated in accordance with work instructions (wi).The photo shows the expected product and complaint issue, where a foreign material can be seen.The lot number of the product is not shown.The foreign matter looks like diffused grey spots.The complaint sample was requested on 25th sept 2023, but it was identified that the complaint sample was not available, as the complainant had sent the dressing to an independent laboratory (surgical manufacturers testing laboratory- smtl).As the dressing under complaint was not available, it was not possible to fully investigate the issue.As the complaint sample was not available, a capa (corrective action / preventive action) and a root cause investigation could not be raised.Without the complaint sample, it is not possible to identify the foreign matter.The grey diffused spots on the dressing look similar to previous examples of foreign matter which was analyzed to conclude excess silver within the dressing.As this is a dressing containing silver, excess silver can discolor and show up as grey diffused spots.The complainant states the foreign matter spots are hard, but without the sample, it is not possible to confirm this aspect of the complaint.A request has been made to the complainant to request a copy of the independent investigation report from the independent party to help us understand the failure mode and address the issue in future.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.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: d9: device available for evaluation has been selected as yes and date returned to mfg was added.H6: type of investigation under imdrf cause investigation code 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+ EXTRA
• Common Device Name: 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: 17964404
• Report Number: 1000317571-2023-00287
• Device Sequence Number: 15151114
• Product Code: FRO
• UDI-Device Identifier: 00768455132034
• UDI-Public: 00768455132034
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: 413568
• Device Lot Number: 3D04407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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