MAUDE Adverse Event Report: CONVATEC LTD AQUACEL FOAM; DRESSING, WOUND, HYDROPHILIC

Model Number 421927

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 2 of 2 (b)(6).Province of china.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 retailer mentioned to the company representative about two dressings were sealed inside the individual primary package.The seal was incomplete and stuck with piece of dressing.There was no complete dressing inside the individual primary package.The product was not used on patient.A photograph depicting the issue was 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.Convatec foam lite 5x5cm 1x10 ster eur was manufactured under system application product (sap) code 1719849 and manufacturing lot number 2l02236 on 24 november 2022.Lot # 2l02236 was sterilized under work order (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 2l02236.There are 3 other complaints for the affected lot registered within database.One photograph was received for this issue and has been evaluated in accordance with work instructions (wi).The photograph confirms the expected lot, product and the complaint issue, where the two primary sachets show evidence of partial dressings stuck in the sachet seal.A non-conformance/ corrective action / preventive actions (capa) was not necessary for this complaint as the number of affected devices does not reach the aql/complaints per million limit for this issue and batch size.The complaints per million figure this type of issue is 1.57 complaints per million worst case scenario, and 0.06 complaints per million best case scenario.After 132 million dressings have been produced, only 8 have received complaints against.The failure mode of this issue will be understood as multiple dressing in seal complaints have been received in the past.This issue also has similarities to another record in database which, although it was for foreign matter, identified that no vision systems exist on the line to remove the possibility of contamination/open seal complaints dressings reaching the end of the line.Dressings are subject to a manual inspection by operators to identify nonconforming dressings, so it is possible for the non conforming dressings to be missed.The dressings stuck in the seals appear to identify an issue with dressing placement when packing into the primary sachets.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 Description

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

• Brand Name: AQUACEL FOAM
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• 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: 17376488
• MDR Text Key: 319927799
• Report Number: 1000317571-2023-00174
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00768455151189
• UDI-Public: 00768455151189
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 421927
• Device Lot Number: 2L02236
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• 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