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

Model Number	420642
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.(b)(4).
Event or Problem Description
It was reported that the packaging was stained.The product was not used by the patient.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h3: device evaluated by mfg.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.The first piece devices taken from the batch does not show evidence of staining.Aquacel foam ag n/adh10x10(1x10) nai was manufactured under (b)(4) and manufacturing lot number 1k03931 on 30 october 2021.Lot # 1k03931 was sterilised under reference order (b)(4) 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 1k03931.This is the only complaint for the affected lot registered within database.One photograph was 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 staining can be seen on packaging.The sample for the complaint was requested on 20th september 2022 and received on 3rd october 2022.An nc (non-conformance) was opened for this issue for stain on primary packaging.Upon receiving the complaint sample, the sample was inspected to identify that the staining was not on the primary packaging, but instead the external pink pu (polyurethane) material on the dressing itself.Further investigation confirmed this staining was limited to the external surface of the pink pu, and not the foam or hydrofibre beneath.The pink pu material was provided by an external supplier, (b)(4), and is printed with ¿ag¿ symbology.The supplier was contacted, but confirmed this would have been an isolated issue, but that the printing of this symbology was subcontracted.However, this symbology printing is now completed in-house, so no corrective actions would be necessary for the issue.The pink pu batch was checked to identify it had been used in 8 other final product batches.No complaints have been received for this issue against any of the other 8 batches.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 AG FOAM
• 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: 15593819
• Report Number: 1000317571-2022-00329
• Device Sequence Number: 2263523
• Product Code: FRO
• UDI-Device Identifier: 00768455123889
• UDI-Public: 00768455123889
• Combination Product (Y/N): N
• PMA/510(K) Number: K123481
• 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: 10/01/2023
• Device Model Number: 420642
• Device Lot Number: 1K03931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• 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: 12/08/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 01/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2021
• 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