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

Model Number	413571
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant city: (b)(6) hospital.Complainant country: singapore.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: 1049092 manufacturing site: 1000317571.
Event or Problem Description
It was reported that a part of the dressing was found outside the sealed packaging.The event had occurred on 17 sep 2024.The quantity affected was one piece.The product was not used by the patient.A photograph depicting the issue was received from complainant.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h4: device manufacture date h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h11: investigation summary.A batch record review was completed, and no discrepancies were found.All seal integrity tests completed throughout the batch manufacture were satisfactory.Aquacel ag+ wsf 2x45cm (1x5pk) ster eur was manufactured under system application product (sap) code 1708337 and manufacturing lot number 3l00865 on 09 november 2023.System application product (sap) identifies the manufacture date as 10 november 2023, but the batch record confirms production began on 09 november 2023.Lot # 3l00865 was sterilized under run id (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 3l00865.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the product, lot and expected complaint issue where a single sachet has a small piece of dressing sticking out of the sachet and the weld area.The exposed piece of dressing is very dark grey.The acceptable quality levels (aqls) from process instruction (pi) identify seal integrity as 0.40, with an accept 3 and reject 4 based upon a sample of 315 dressings and batch size of 21000 dressings.As only 1 packs remain in distribution centers (dcs), it is likely over 315 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) was necessary to investigate this issue.This batch has been manufactured before a new vision system has been added to the manufacture line.The new vision system would be capable of identifying this dressing in seal, so it is most likely that dressings displaying this malfunction would now be identified and rejected automatically on the line.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+ RIBBON WSF
• 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: 20395279
• Report Number: 1000317571-2024-00075
• Device Sequence Number: 15056854
• Product Code: FRO
• UDI-Device Identifier: 00768455132218
• UDI-Public: 00768455132218
• 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): 09/17/2024

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 Expiration Date: 11/01/2025
• Device Model Number: 413571
• Device Lot Number: 3L00865
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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