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

Model Number	413568
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant country: brazil.Name of 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 one piece of sterile material package had open seal.The product was not used by patient.No photo is available at this time.
Additional Manufacturer Narrative
Correction: h4: device manufacture date - in initial emdr, the manufacture date was added as 16 october 2023, but the batch record confirms the manufacture date is 27 october 2023.Hence, it has been corrected.Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation 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+ extra 15x15cm(1x5pk)ster eur was manufactured under system application product (sap) code 1708334 and manufacturing lot number 3k02708 on 27 october 2023.System application product (sap) identifies the manufacture date as 16 october 2023, but the batch record confirms manufacture began on 27 october 2023.Lot # 3k02708 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 3k02708.This is the only complaint for the affected lot registered within database.No photographs were received for this issue, so it was not possible to evaluate them in accordance with work instructions (wi).Additional information, photographs and the complaint samples were requested on 08 november 2024, but it was advised that no further information, no images and no samples were available for the issue as the complaint was received from brazilian authorities anvisa (national health surveillance agency).I was advised that typically which we cannot gain further information from reports made by anvisa.As no images or evidence of the complaint were received, it was not possible to confirm the complaint.The wording in the complaint record insinuates multiple primary packs have open seals, but no confirmation of the actual affected number was given.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 33600 dressings.As only 7 packs remain in distribution centers (dcs), it is likely over 315 dressings have been exhausted.No other complaints have been received for the batch, and without confirmation if more than 1 dressing has been affected, this issue remains below acceptable quality levels (aqls).As no photos or samples were received to confirm or investigate the complaint, further investigation is not possible.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: 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: 20816333
• Report Number: 1000317571-2024-00089
• Device Sequence Number: 8928083
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: Health Professional
• Device Expiration Date: 10/01/2025
• Device Model Number: 413568
• Device Lot Number: 3K02708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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