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

Model Number 422301

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  

Event Description

The end user reported that the two dressings from the same lot had dressing packaging compromised prior to use.The product was received from the retailer and was not sent in the original market unit box.Individual dressings were sent inside a ziploc-styled plastic bag.One of the dressings was already opened, compromising the sterility of the dressing.The other dressing was sealed into the edge of the package, compromising the sterility of the dressing and damaging the dressing.The product was not used by patient.The photographs depicting the issue were received from the end user.

Manufacturer Narrative

Device 1 of 2.E1: 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

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.H10: investigation summary.A batch record review was completed and no discrepancies were found.All seal integrity tests completed throughout the batch manufacture were satisfactory.Aq ag+ advantage 1x45cm (1x5) ster us was manufactured under system application product (sap) code 1708364 and manufacturing lot number 3f02754 on 26 june 2023.This date is reflected as the start date for the batch within the batch record, but sap identifies the batch was manufactured 15 june 2023.It is not known why this date is written sap.Lot # 3f02754 was sterilized 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 3f02754.This was the only complaint for the affected lot registered within database.Three 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 can be seen, one with a small piece of the ribbon dressing visible on the sachet seal.The corrective actions/preventive action (capa) has been raised recently for an open seal identified on a batch produced on the same manufacturing line (universal line).The investigation identified that the flipper cylinder on the line slowed down as fibre was catching pusher on the upstroke.The sensor guides were not lined up and first fold position and symmetry by moving securing clamps holding the reed switches.The process instruction for the line (pi12-028 v35.0) did not give adequate instructions for the set up of the cylinder fold sensors.It was also identified that operators were not trained against the pi12-028 or the standards of acceptability.There have now been 3 complaints for dressing in seal from the universal manufacturing line (including this complaint), and it was not appropriate to raise a new capa while the capa already open still has open actions being implemented.Previously, complaints for this malfunction code and machine were zero.The implementation dates for the actions will be noted and any further complaints checked against those dates.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: 18235358
• MDR Text Key: 329329272
• Report Number: 1000317571-2023-00321
• Device Sequence Number: 1
• Product Code: FRO
• UDI-Device Identifier: 00768455154401
• UDI-Public: 00768455154401
• Combination Product (y/n): N
• PMA/PMN Number: K173675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 422301
• Device Lot Number: 3F02754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2023
• 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