BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM

    MDR report key: 18417245 · Received December 29, 2023

    Report

    Report Number
    1000317571-2023-00329
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Report Date
    December 4, 2023
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455123865
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 1000317571.

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 2. E1: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. SAMPLES ARE AVAILABLE FOR EVALUATION; HOWEVER, SHIPPING IS IN PROGRESS. 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.

    Additional Manufacturer Narrative · 0

    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 IN-PROCESS STATE SAMPLE QUALITY CHECKS WERE SATISFACTORY. AQUACEL FOAM N/ADH 15X20(1X5) NAI WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE (B)(4) AND MANUFACTURING LOT NUMBER 2K01141 ON (B)(6) 2022. LOT # 2K01141 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 2K01141. THIS IS THE FIRST COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE, WITH A SECOND FOR SQUASHED AND WRINKLES DRESSING WHICH IS CONSIDERED TO BE UNRELATED. THREE (3) PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE AND HAS BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTION (WI). THE PHOTOGRAPH CONFIRMS THE EXPECTED PRODUCT AND THE COMPLAINT ISSUE WHERE FOREIGN MATTER IN THE FORM OF A BLACK FLAKY SUBSTANCE IS SEEN ON THE EDGE OF THE PINK POLYURETHANE (PU) OF THE DRESSING. THE COMPLAINT SAMPLE WAS REQUESTED, ON (B)(6) 2023 AND RECEIVED ON (B)(6) 2023. THE SOILED SAMPLE WAS RECEIVED AND SENT TO THE LAB FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS TO IDENTIFY THAT THE FOREIGN MATTER IS A TYPE OF LUBRICANT MIXED WITH HYDROFIBRE FIBERS. THE CONTAMINATION IS MOST LIKELY CAUSED BY HYDROFIBRE DEPOSITION INTO LUBRICATED, MOVING MACHINE PARTS, WHICH IS THEN PICKED UP BY THE DRESSING BRUSHING PAST. THIS HAS BEEN PREVIOUSLY IDENTIFIED IN COMPLAINT FOR WHICH NC (NON-CONFORMANCE) RECORD WAS OPENED. THIS IS ALSO RELATED TO CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) WHICH HAD ACTION RELATING TO CLEAN TO INSPECT, LUBRICATE AND TIGHTEN (CILT) STANDARDS BEING ADDED TO THE PROCESS INSTRUCTION (PI) DOCUMENT FOR THE PROCESS. THIS CAPA IS STILL IN PROGRESS GOING THROUGH EFFECTIVENESS CHECKS, SO NO NEW CAPA IS RAISED FOR THIS COMPLAINT AS THE PREVIOUS WILL BE COVERING THIS BATCH WITHIN BOUNDING AS THE PRODUCT WAS MANUFACTURED BEFORE IMPROVEMENT SHAVE BEEN MADE. DRESSINGS ARE ALSO INSPECTED BY HUMAN OPERATORS AT SPEED, SO IT IS POSSIBLE FOR SOME DEFECTS TO 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: (B)(4) MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER (DIRT) FOUND ON DRESSING IN TWO PACKETS. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236345 AQUACEL FOAM DRESSING, WOUND, HYDROPHILIC NAC CONVATEC LTD 420637 2K01141 00768455123865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown