BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR 13.5FR X 13.5CM PC KIT

    MDR report key: 3003614 · Received February 12, 2013

    Report

    Report Number
    1317749-2013-00073
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Report Date
    February 4, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES ON (B)(6) 2013, AFTER A DIALYSIS THERAPY SESSION, BLOOD WAS FOUND IN THE VENOUS LUMEN RUPTURE. THE NEPHROLOGIST WAS INFORMED, WHO THEN ORDERED A SUSPENSION IN THERAPY. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62036 MAHURKAR 13.5FR X 13.5CM PC KIT DIALYSIS CATHETER MSD COVIDIEN 8888135133 131522X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK