BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX19.5 CE MAHURKAR

    MDR report key: 2771399 · Received September 27, 2012

    Report

    Report Number
    1317749-2012-00222
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    July 31, 2012
    Report Date
    September 3, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012, THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER WAS PLACED ON (B)(6) 2012. THE CATHETER WAS LOCATED IN THE RIGHT SUBCLAVIAN. ON (B)(6) 2012, THE CATHETER BROKE AT THE Y JUNCTION OF THE CATHETER. HEPARIN WAS STOPPED. A GUIDE WIRE WAS INSERTED AND THE CATHETER WAS REMOVED. A NEW CATHETER WAS PLACED USING THE SAME GUIDE. UPON REMOVING THE GUIDE WIRE, IT BROKE AND THEREFORE THE NEW CATHETER AND GUIDE WIRE WERE REMOVED. A NEW GUIDE WIRE AND CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE CATHETER WAS PLACED USING THE SAME VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT 11.5FX19.5 CE MAHURKAR DIALYSIS CATHETER MSD COVIDIEN 8813793013 203430X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK