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); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 12 of 14.Initial reporter: (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: 1049092 manufacturing site: 1000317571.
Event or Problem Description
It was reported that complainant found an unglued (opened) package on the weld.It was unknown whether the product was used on patient or not.Photographs depicting the issue were 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 h10: investigation summary a batch record review was completed and no discrepancies were found.All peelback sample tests completed throughout the batch manufacture were satisfactory.The batch was identified as having been under deviation, relating to the upper limit of the top seal set points, but as was concluded within the investigation, this was not the reason for the seals being unsealed.Aquacel ag+ extra 15x15cm(1x5pk)ster eur was manufactured under system application product (sap) code 1708964 and manufacturing lot number 2m01377 on (b)(6) 2022.Lot # 2m01377 was sterilized under lot 2173-33711a 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 (nc) was identified during the manufacturing process of lot 2m01377.This was the only complaint for the affected lot registered within database.Six photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the expected lot number, product and the complaint issue where the open seal are evident in a number of sachets.The complaint samples were requested on (b)(6) 2023 and received on (b)(6) 2023.A corrective and preventive actions (capa) was opened for this complaint issue and investigation identified that this issue was similar to the issue and failure mode identified in previous nc.The investigation of the complaint samples identified manufacturer splice tape adhered to side seals causing unsynchronized web to cross seals and knife.This resulted in the sachet being cut and sealed in the incorrect position.As the manufacturer splice had not been addressed by an operator upon an audible alarm, awareness training has been assigned for relevant operators.Corrective and preventive actions (capa) had been opened to address investigation findings, including review of spice allowance and implement a code change to stop the line if a top splice is detected and hasn't been acknowledged by the operator.This batch has been produced before any improvements have been made to the manufacturing line, and before the non-heat proof red tape provided by the supplier of the foil reels.Further instances of this open seal failure mode will be monitored.This issue will be monitored through the post market product monitoring review process.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
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 ; 3365424679
• MDR Report Key: 17036923
• Report Number: 1000317571-2023-00099
• Device Sequence Number: 15067799
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 12/01/2024
• Device Model Number: 413568
• Device Catalogue Number: 413568
• Device Lot Number: 2M01377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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