BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM

    MDR report key: 17236458 · Received June 30, 2023

    Report

    Report Number
    1000317571-2023-00153
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Report Date
    June 7, 2023
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455129089
    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:H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONSH10: INVESTIGATION SUMMARYAQUACEL FOAM ADH 8X8CM 1X10 NAI WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1707736 AND MANUFACTURING LOT NUMBER 2B03778 ON 01 MARCH 2022.LOT # 2B03778 WAS STERILIZED UNDER WORK ORDER 3074772 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 2B03778. THERE IS ONE OTHER COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE, WHICH RELATES TO DAMAGED PACKAGING.SIX PHOTOGRAPHS WERE RECEIVED FOR THIS COMPLAINT, EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). THE PHOTOGRAPHS CONFIRM THE EXPECTED PRODUCT, LOT AND COMPLAINT ISSUE, WHERE TINY FLECKS OF BLACK/BROWN CAN BE SEEN ON THE SURFACE OF THE PINK PU OF THE DRESSINGS. THE COMPLAINT SAMPLES WERE REQUESTED ON 8TH JUNE 2023 AND RECEIVED ON 20TH JUNE 2023 FOR TESTING.THE COMPLAINT SAMPLES WERE SENT FOR LABORATORY TESTING ON 26TH JUNE 2023 TO IDENTIFY THE BLACK/BROWN SPECS WERE MADE UP OF IRON OXIDE, SO WHAT APPEARED TO BE DRIED UP RUSTY WATER. THE AREAS OF CONTAMINATION WERE SMALL, WITH THE SPECS OF BROWN/BLACK CONTAMINATION RANGING FROM 1.5MM TO SMALLER THAN 0.5MM IN DIAMETER. IT WAS ALSO POSSIBLE TO RUB THE COLORED SPECS FROM THE SURFACE OF THE PINK PU WITH A FINGER. A LINE STUDY WAS COMPLETED ON THE DELTA 3 LINE TO IDENTIFY POSSIBLE AREAS OF RUST, TOOLING FOR 8X8 DRESSINGS, SPLICE STATIONS, KNIFE AND SCISSORS AND DRESSINGS (8X13 DRESSINGS WERE ON THE LINE AT THE TIME). THE PINK PU OF THE DRESSING IS INTRODUCED AT AXIS 11 (CONVERTOR), AND A SMALL REDDISH SPEC WAS FOUND BETWEEN AXIS 13 AND 14 ON UNCUT. ONCE TOUCHED, IT SMUDGED, LIKE IT WAS A POWDER AND DISAPPEARED. HAD THIS BEEN A SPEC OF DRIED RUST, IT IS CONFIRMED THAT THE RUSTY WATER IS NOT ENTERING THE PROCESS AT THAT POINT AS THE RUST WOULD LIKELY BE IN A LIQUID FORM AND THE SPECS WERE NOT WET. NO RUST WAS FOUND IN THE VICINITY. A NUMBER OF TOOL CHANGES AND SHARPENING OF TOOLING WILL HAVE OCCURRED SINCE THE BATCH WAS PRODUCED IN FEBRUARY 2022, MEANING THAT IT IS LIKELY ANY ORIGINS OF THE SPOTS OF RUST WILL NOW NOT BE AVAILABLE TO SEE. SOME BROWNISH RED SMUDGING WAS SEEN ON PINK PU, BUT IT IS THOUGHT THAT COULD BE THE PINK PU COLORANT. NONCONFORMITY (NC) (REOPENED AS CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) IN NEW DATABASE SYSTEM) WAS OPENED AFTER A COMPLAINT WAS RECEIVED FOR FOREIGN MATTER ON A DRESSING, WHICH WAS AN IRON-OXIDE-BASED METALLIC CONTAMINATION. WHILE THIS WAS FOR ANOTHER MANUFACTURING LINE, THE REASON THE CONTAMINATION HAS REACHED THE FINAL DRESSING PRIMARY PACK IS THAT THE LINES DO NOT HAVE A VISION SYSTEM, AND INSTEAD RELY ON MANUAL HUMAN INSPECTION, WHICH MAY NOT IDENTIFY 100% OF ALL DEFECTS IN FINAL DRESSING PACKS. IT IS ALSO POSSIBLE THAT THE BROWN/BLACK SPOTS ORIGINATE FROM THE SUPPLIER OF THE PINK PU, BUT THE SUPPLIER WAS NOT CONTACTED IN THIS CASE, AS THE SPECS COULD NOT BE FOUND ON COMPLETE REELS. AS NO SAMPLES COULD BE FOUND IN SITU ON THE INCOMING PINK PU, IT WAS NOT POSSIBLE TO SEND THE SUPPLIER A SAMPLE.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 NUMBERREPORTING SITE: 1049092MANUFACTURING SITE: 1000317571

    Additional Manufacturer Narrative · 0

    MDR 1000317571-2023-00153 / DEVICE 17 OF 25 E1: COMPLAINANT CITY: (B)(6). COMPLAINANT STATE: (B)(6). . COMPLAINANT COUNTRY: KOREA, REPUBLIC OF NAME OF AFFILIATION: S MEDI 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NURSE FOUND BLACK DOTS ON TWENTY-FIVE INDIVIDUAL DRESSINGS OUT OF FIVE MARKET UNITS. THE BLACK DOTS WERE A PARTICULATE RATHER THAN A FOREIGN MATTER. THE DOTS APPEARED TO BE SMALL, POSSIBLY A DRIED LIQUID ON THE SURFACE OF THE PINK PU, SAMPLES HAVE ALSO BEEN RECEIVED FOR FURTHER INVESTIGATION OF THE COMPOSITION AND IDENTIFICATION OF DOTS. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855219 AQUACEL FOAM DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LTD 420804 2B03778 00768455129089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown