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

Model Number 422359

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant information: (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.(b)(4).

Event Description

It was reported that there was visible hair in sealed sachet.The product was not used by patient.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 h10: investigation summary a batch record review was completed, and no discrepancies were found.Aq foam pro 8x8cm 1x10pk ster eur was manufactured under standard operating procedure (sop) code 1727479 and lot number 2d03396 manufactured on 29 april 2022.Lot # 2d03396 was sterilised under order (b)(4) and released on review of results of sterilisation provided by sterilisation company steris.All results were within specification and products were released.No nonconformity was registered during the manufacturing process of lot 2d03396.This was the only complaint for the affected lot registered within database.Four photographs were received for this issue and have been evaluated in accordance with work instruction (wis).The photograph confirmed the expected lot number product and complaint issue.The foreign matter was a hair that appeared to be stuck in the top cross seal of the primary sachet.A non-conformance record was raised, and an investigation completed to identify the how the foreign matter had gotten into the primary sachet.It was confirmed current personal protective equipment (ppe) was suitable for use in the controlled environment, but it did not allow movement which may allow loose hairs to transfer onto garments and in turn may transfer onto material and products while working in the controlled environment.Hair may also be transferred from supplier materials which cannot be ruled out as a possible cause.Good manufacturing practice (gmp) audits are regularly conducted to ensure all good manufacturing practice (gmp) activities are being followed, and that during these good manufacturing practice (gmp) audits, relevant personnel will be reminded of the gowning up requirements on a regular basis.No further actions are required as part of this non-conformance.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 FOAM
• 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: 15646075
• MDR Text Key: 303551467
• Report Number: 1000317571-2022-00332
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00768455157341
• UDI-Public: 00768455157341
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 422359
• Device Catalogue Number: 422359
• Device Lot Number: 2D03396
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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