BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIODYNAMICS 20 CM SCHON DUO FLOW CATHETER

    MDR report key: 150125 · Received February 20, 1998

    Report

    Report Number
    150125
    Event Type
    Death
    Date Received
    February 20, 1998
    Date of Event
    January 22, 1998
    Report Date
    February 19, 1998
    Manufacturer
    MEDCOMP
    Product Code
    LFJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEMODIALYSIS CATHETER WAS INSERTED ON 1/21/98 AND ON 1/22/98 PT PULLED BOTH LUMENS OF THE CATHETER CAUSING THEM TO BREAK RESULTING IN THE PT'S DEATH FROM EXSANGUINATION. THE PT HAD PERIODS OF DEMENTIA AND WAS NOT ORIENTED ENOUGH TO CALL FOR HELP. SHE HAD BEEN KNOWN TO PULL AT OTHER CATHETERS IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIODYNAMICS 20 CM SCHON DUO FLOW CATHETER Implant 20 CM HEMODIALYSIS CATHETER LFJ MEDCOMP * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death