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

Model Number 413568

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device 8 of 14.E1: complainant country: poland 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: 1049092.Manufacturing site: 1000317571.

Event 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.

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 19 december 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 19 may 2023 and received on 24 may 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 Description

To date no additional patient or event details have been received.

• Brand Name: AQUACEL AG+ EXTRA
• Type of Device: 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: 17036924
• MDR Text Key: 316297770
• Report Number: 1000317571-2023-00095
• Device Sequence Number: 1
• Product Code: FRO
• UDI-Device Identifier: 00768455132034
• UDI-Public: 00768455132034
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1