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

Model Number	422357
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a hair inside the primary packaging identified during the labeling process.The product was not used by patient.The photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
E1: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review was completed and no discrepancies were found.Aquacel foam pro 10x10cm 1x10pk nai was manufactured under system application product (sap) code 1724191 and lot number 1l04498 manufactured on 02 december 2021.Lot # 1l04498 was sterilized under work order 3019378 and released on review of results of sterilization provided by sterilization company sterigenics.All results were within specification and products were released.No nonconformity was registered during the manufacturing process of lot 1l04498.This is the only complaint for the affected lot registered within database.One (1) photograph was received for this issue and has been evaluated in accordance with work instruction (wi).The photograph confirm the expected lot number, product and complaint issue.The foreign matter is a hair that can be seen on the top left corner of the dressing within the primary pack.Two previous non-conformance records have been raised within the last 12 months for foreign matter (hair).Investigation was completed to identify the how the foreign matter had reached the primary sachet.It was confirmed current personal protective equipment (ppe) is suitable for use in the controlled environment, but it does 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.Awareness training was completed for relevant shifts on this complaint issue and images received, although it is acknowledged that the hair would not necessarily have been easily identifiable when the dressings have been manually inspected during manufacture.As these products are human inspected and are not inspected by a vision system, there is the possibility that defects can be missed.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
• Common Device Name: 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: 18370750
• Report Number: 1000317571-2023-00326
• Device Sequence Number: 20792236
• Product Code: NAC
• UDI-Device Identifier: 00768455157327
• UDI-Public: 00768455157327
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: 422357
• Device Lot Number: 1L04498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown