BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR

    MDR report key: 2232206 · Received August 26, 2011

    Report

    Report Number
    MW5021922
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 26, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO INSERT A TEMPORARY DIALYSIS CATHETER, PHYSICIAN CANNULATED THE VEIN AND THREADED THE CATHETER BUT WAS UNABLE TO RETRACT STYLUS. ATTEMPTED X 2 WITH TWO DIFFERENT ACUTE DUAL LUMEN CATHETER KITS WITH THE SAME RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHURKAR MAHURKAR ACUTE DUAL LUMEN CATHETER KIT; 11.5 FR/CH - MPB COVIDIEN 8830415003 114715X

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR