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

Model Number	420648
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant street address: (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 seal integrity tests completed throughout the batch manufacture were satisfactory.Aquacel foam agadh sacral 20x16.9 1x5nai was manufactured under system application product (sap) code 1703980 and manufacturing lot number: 4b02755 on 20 february 2024.Lot#: 4b02755 was sterilized under work order: (b)(4) 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: 4b02755.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue initially, in which it was difficult to identify the complaint issue.Further images were requested on 18 oct 2024 and 5 further images were received on 21st oct 2024.The additional photographs confirm the product, lot and expected complaint issue where a single primary sachet has a dressing sealed into the weld area causing an opening in the package seal.The acceptable quality levels (aqls) from process instruction identify seal integrity as 0.40, with an accept 2 and reject 3 based upon a sample of 200 dressings and batch size of 5400 dressings.As only 230 packs remain in distribution centers (dcs), it is likely over 200 dressings have been exhausted, and as only a single dressing has been reported for an open seal, this issue remains below acceptable quality levels (aqls), so no corrective action / preventive actions (capa) is necessary to investigate this issue.Following review of the images, it is most likely that the dressing in seal has been caused by a dressing placement issue, due to incorrect placement on the manufacturing line peg conveyor.This may be due to a peg on the conveyor becoming loose, or the dressing may have caught on something to move it while travelling on the peg conveyor.Dressing inspection is also completed by operators, and it is not always possible to identify all issues at inspection at validated line speeds.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
It was reported by the distributor that one piece of dressing had open seal.The product was not used by patient.The photographs depicting the issue were received from the complainant.

• 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 27409 ; 3365424679
• MDR Report Key: 20638810
• Report Number: 1000317571-2024-00084
• Device Sequence Number: 7461650
• Product Code: FRO
• UDI-Device Identifier: 00768455123810
• UDI-Public: 00768455123810
• 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
• Report Date (Section B): 10/17/2024

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: 420648
• Device Lot Number: 4B02755
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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