BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELL LEAD FOLEY CATHETER

    MDR report key: 2442879 · Received January 20, 2012

    Report

    Report Number
    3003903031-2012-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    October 26, 2011
    Report Date
    January 20, 2012
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Product Code
    EZL
    PMA / PMN Number
    K082815
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE INVESTIGATED HISTORY RECORD OF THIS LOT AFTER RECEIVING FEEDBACK, BUT DIDN'T FIND ANY ABNORMALITY. WE CAN ONLY DO ANALYSIS FOR THE POSSIBLE CAUSES FROM THE FEEDBACK INFO. AS NO RECEIVING THE SAMPLES. A SMALL PIECE OF LATEX DEBRIS MAY APPEAR AT THE LUMEN OF CONJUNCTION BETWEEN INFLATION FUNNEL AND THE DRAINAGE FUNNEL, WHEN THE BALLOON IS DEFLATED, THE FLASH COULD JAM THE INFLATION FUNNEL. IT WAS CAUSED BY THE DIPPING MOULDS FRAYING AFTER LONG TIME USE, FURTHERMORE, THE FRAYING MOULDS WEREN'T REPLACED IN TIME AS THE DIFFICULTY AND LONG PROCESSING CYCLE OF CURRENT MOULD PRODUCTION PROCESS. MOLDS WERE REPLACED AS A RESULT OF THE INSPECTION. ONE HUNDRED PERCENT UNIT INSPECTION FOR INFLATION AND DEFLATION IS CONDUCTED DURING THE MANUFACTURING PROCESS TO PREVENT THE DEFLATION FAILURE. IT MAY HAVE BEEN BECAUSE THE INSPECTORS DIDN'T PICK OUT THE DEFECTIVE SAMPLE THAT COULD HAVE CAUSED DEFLATION DIFFICULTLY. AS A RESULT OF THIS ALL INSPECTORS HAVE BEEN RETRAINED APPROPRIATELY.

    Description of Event or Problem · 1

    DURING THE HYSTEROSALPINGOGRAPHY PROCEDURE, RADIOLOGIST MADE MULTIPLE ATTEMPTS IN ORDER TO DEFLATE A FOLEY BALLOON CATHETER AND TO REMOVE IT FROM PATIENT'S FALLOPIAN TUBES. SINCE THE BALLOON COULD NOT BE DEFLATED, DOCTOR CUT THE CATHETER ACROSS AND REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELL LEAD FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL WELL LEAD MEDICAL CO. LTD 2 WAY. 3-5CC 8 FR 110510769

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention