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

Model Number 403706

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

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

Event Date 06/13/2023

Event Type  malfunction  

Event Description

The head nurse reported that on 13 jun 2023 when she opened one piece of company's known dressing, she found that the dressing was pressed on the edge of the package and could not be used.A photograph depicting the issue was received from the complainant.

Manufacturer Narrative

E1: complainant city: chongqing, complainant phone: (b)(6) complainant country: 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.

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.Aquacel ag drs 5x5cm (1x10pk) ster nai was manufactured under system application product (sap) code 1186135 and manufacturing lot number 2c02446 on 16 mar 2022.Lot # 2c02446 was sterilized under run id 2173-26984 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 2c02446.There are two complaints for the affected lot registered within database, both related.This complaint identifies the dressing trapped in the primary package seal, and the other complaint is for additional product found in the sachet, which was a separate portion of the trapped dressing was found in the primary sachet.One photograph was received for this issue and has been evaluated in accordance with work instruction (wi).The photograph confirms the expected complaint issue where a single dressing is found trapped in the seal, with another portion of the dressing also within the sachet.It was not possible to identify the product or lot number from the photograph.A corrective action / preventive action (capa) was raised for this complaint, 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.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 AG BASE
• 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: 17278041
• MDR Text Key: 318841033
• Report Number: 1000317571-2023-00111
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: K013814
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 403706
• Device Lot Number: 2C02446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2022
• 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