BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUBCLAVIAN CATHETER

    MDR report key: 10982 · Received January 18, 1994

    Report

    Report Number
    MW1000421
    Event Type
    Death
    Date Received
    January 18, 1994
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    DQO
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    BECAUSE OF NUTRITIONAL FLUID INFILTRATIONS IV LINE REPLACED. CONSENT SIGNED UNDER DURESS. PT NOT INFORMED OF ANY RISKS PRIOR TO THE SUBCLAVIAN CATHETER INSERTION. CATHETER LEAKED GROSS BLOOD AT CUP LINK; ALSO MALFUNCTIONED. LEAKED GROSS BLOOD 1 1/2" DIAMETER AT SITE, WEAKENING PT PHYSICALLY. PT SUFFERED TWO HEART ATTACKS CAUSING CRITICAL CONDITION AND PLEURAL EFFUSION. NO ICU OR CCU AVAILABLE. HOSPITAL CAUSED SICKNESS AND 2 + EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBCLAVIAN CATHETER Implant DQO BECTON DICKINSON & CO. 39-7551, 39-757-1 RECALLED CLASS II

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Not Applicable| D| H| L| R