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

Model Number 177901

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  

Event Description

It was reported that the product was cut and caught in seal.Usage of device was unknown.The photographs depicting the issue were received from complainant.

Manufacturer Narrative

Device 1 of 5.Complainant country: poland based on the available information, this event is deemed to be a reportable malfunction.Pm logs had been checked and they were all completed with no discrepancies.A batch record review was completed and no discrepancies were found.Aquacel drs 5x5cm (1x10pk) ster ceu was manufactured under sap code 1161262 and manufacturing lot number 0f01132 on 11 june 2020.Lot 0f01132 was sterilised under reference uk32s12446568-1-1 and released on review of results of sterilisation provided by sterilisation company steris.All the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 0f01132.Nine complaints exist for this affected lot registered in database, reported partial cut dressings, product in seal, empty primary packs and short count.The other complaint issues reported for this batch indicated a common failure mode.No photographs were attached to the complaint record initially, but additional images were received upon request for this complaint.Four photographs were received and has been evaluated in accordance with working instructions.The photographs confirmed the expected lot number, product, and the complaint issue where three dressings were identified as trapped in the seal and cut.The images showed the individual sachet numbers 12670, 12671 and 12544 of the affected dressings.2 additional dressing were identified to also have dressing stuck in the seal for this reported batch, with additional sachet numbers reported as 12489 and 12490.A nonconformance was opened for this complaint issue.A data review was raised, but as other complaints and non-conformances had been raised for similar failures on doyen 3, an older investigation was still relevant for this issue and failure mode.The investigation was completed in jan 2021, confirms the most probable causes of open product/product in seal on doyen 3 line.Corrective actions to address the issues identified were implemented in dec 2020 for doyen 3 and further validation activities completed in quarter 4 (q4) 2021.As the affected batch was manufactured in june 2020, this was before the improvements to the line were made.The affected batch is currently held on a stop ship order with the requirement for a rework/reinspection to be completed before returning saleable stock to market.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: 1049092 manufacturing site: 1000317571.

• Brand Name: AQUACEL BASE
• 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: 15333473
• MDR Text Key: 305590175
• Report Number: 1000317571-2022-00145
• Device Sequence Number: 1
• Product Code: NAC
• 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
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 177901
• Device Lot Number: 0F01132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2020
• 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