BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMODIALYSIS

    MDR report key: 3844811 · Received May 16, 2014

    Report

    Report Number
    3006260740-2014-00257
    Event Type
    Death
    Date Received
    May 16, 2014
    Date of Event
    December 17, 2012
    Report Date
    April 24, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PATIENT HAD CATHETER PLACED (B)(6) 2012. WHEN PATIENT CAME OUT OF CLINIC, PATIENT DID NOT FEEL WELL. PATIENT MOTHER ASKED PATIENT WHAT WAS WRONG AND PATIENT SAID IT FELT ASD THOUGH THE TIP OF THE CATHETER WAS INSERTED TOO FAR. PATIENT WAS TAKEN HOME BY MOTHER AND WHILE AT HOME, PATIENT DIED. ACCORDING TO CORONER FROM PRIVATE AUTOPSY, THE CATHETER PUNCTURED THE PATIENT'S HEART, ULTIMATELY KILLING PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293832 HEMODIALYSIS CATHETER HEMODIALYSIS IMPLANTED MSD BARD ACCESS SYSTEMS INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death