BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURA-FLOW

    MDR report key: 1013005 · Received March 14, 2008

    Report

    Report Number
    MW5005855
    Event Type
    Death
    Date Received
    March 14, 2008
    Date of Event
    June 14, 2007
    Report Date
    March 6, 2008
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD AN ANGIODYNAMICS DURA-FLOW CHRONIC HEMODIALYSIS CATHETER IN THE RIGHT THIGH THAT CAME APART AT HOME AND BECAME DISLODGED CAUSING HER TO BLEED TO DEATH. THE CATHETER WAS A "ROTATING WING" THAT IS SUTURED TO THE SKIN TO HOLD THE CATHETER IN PLACE. THIS "WING" FITS LIKE A CUFF OVER THE END OF THE CATHETER ON THE OUTSIDE OF THE BODY. THE CUFF EASILY "SNAPS" LOOSE FROM THE CATHETER, THUS ALLOWING THE CATHETER TO SLIDE OUT OF THE BODY. THE PRODUCT WAS USED PROPERLY, BUT DUE TO POOR DESIGN THE CATHETER CAN SLIDE OUT OF THE BODY WHILE THE CUFF REMAINS SUTURED TO THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-FLOW CHRONIC HEMODIALYSIS CATHETER MSD ANGIODYNAMICS 15.5F

    Patients

    Seq Age Sex Outcome Treatment
    1 Death