BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX19.5CM MAHURKAR

    MDR report key: 1080613 · Received July 17, 2008

    Report

    Report Number
    1317749-2008-00127
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 3, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE CATHETER KINKED DURING INSERTION, AND THEY WERE UNABLE TO DIALYZE POST-INSERTION. THIS CALLED FOR CATHETER REPLACEMENT. THE CATHETER WAS 19.5 CM AND PLACED SUBCLAVIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT 11.5FX19.5CM MAHURKAR DIALYSIS CATHETER MSD TYCO HEALTHCARE/KENDALL 8813793009 806001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN