MAUDE Adverse Event Report: CONVATEC LTD AQUACEL AG+ EXTRA; NOT APPLICABLE

Model Number	413569
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
Common device name: dressing, wound, drug.Initial reporter complainant street address: (b)(6).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 or Problem Description
It was reported that the package was damaged with open seal.The product was not used on 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: 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.Aquacel ag+ extra 20x30cm(1x5pk)ster eur was manufactured under system application product (sap) code 1708335 and manufacturing lot number 2b00919 on 10 february 2022.Lot 2b00919 was sterilised under 2163-2354a and released on review of results of sterilisation provided by sterilisation company steris.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 2b00919.This is one of two complaints within database against this lot, with the other complaint indicating a short count in shipper.One photograph was received for this issue and have been evaluated in accordance with work instructions (wis).The photograph confirms the expected product and the complaint issue where the open seal and dressing in seal is evident.The photograph does not confirm the affected lot number.A nonconformance was opened for this complaint issue.No investigation was necessary as it was identified from the batch manufacture date that this dressing was manufactured on prior to open seal improvements made to the line.Ngnc/pause tooling function has been validated on relevant lines at the deeside site to identify misaligned dressings on the line which may be crimped with the dressing in the incorrect place.The ngnc/pause tooling function was not validated on this line at the time of manufacture and was instead validated on the line on 30th march 2022.Improvements have already been added to this manufacturing line as part of corrective and preventive actions (capa).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+ EXTRA
• Common Device Name: NOT APPLICABLE
• 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: 15604766
• Report Number: 1000317571-2022-00330
• Device Sequence Number: 13987402
• Product Code: FRO
• UDI-Device Identifier: 00768455132041
• UDI-Public: 00768455132041
• 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): 09/21/2022

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: 02/01/2024
• Device Model Number: 413569
• Device Catalogue Number: 413569
• Device Lot Number: 2B00919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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