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

Model Number 413566

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284); Packaging Problem (3007)

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

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 2 e1: (b)(6).Photo was reviewed.Discoloration was caused by oxidizing due to heat from sealing and product exposed to light.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

The nurse reported that two dressings were in poor condition.At the time of opening the device to perform the cure, the product had a different color and where it was sealed, it affected the internal product.The products were not used.The photographs depicting the issue were received from the complainant.

Event Description

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

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.Aquacel ag+ extra 5x5cm (1x10pk)ster eur was manufactured under system application product (sap) code 1708330 and manufacturing lot number 2k03160 on 02 november 2022.Lot # 2k03160 was sterilized under run id 2163-3019a 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 2k03160.This is the only complaint for the affected lot registered within database.Seven photographs were received for this issue and have been evaluated in accordance with work instruction (wi).The photographs confirm the product, lot and expected complaint issue where two open sachets are shown with the dressing trapped in the seal.A corrective action / preventive action (capa) was raised for previous complaints for dressing in seal, and an investigation completed.Investigation identified that the alteration of the top web print completed while the line was running resulted in dressing in seal.Operators were asked why it was necessary to alter the print, and it was identified operators would adjust print to reduce the number of print rejects.Access to alter the print web has since been restricted to engineer level, and it has been communicated that print position is only to be altered during batch set up and not during the machine running.The bounding for this previous corrective action / preventive action (capa) included all of the 5x5cm dressing sizes manufactured on doyen 3, including this batch.This batch is not listed within the corrective action / preventive action (capa) as there was no product remaining in dcs at the time of bounding.As improvements are being made as a result of the corrective action / preventive action (capa), no further corrective action / preventive action (capa) is required.The previous capa also had a health hazard evaluation (hhe) within record in database, identifying potential health hazards, so future complaints of this kind can be closed to the original corrective action / preventive action (capa) and health hazard evaluation (hhe).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.

• 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: 17709929
• MDR Text Key: 322943911
• Report Number: 1000317571-2023-00198
• Device Sequence Number: 1
• Product Code: FRO
• UDI-Device Identifier: 00768455132010
• UDI-Public: 00768455132010
• 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,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 413566
• Device Lot Number: 2K03160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2022
• 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