BEUDAMED
    FDA Adverse Event Death Summary report: N

    VYGM

    MDR report key: 76120 · Received March 17, 1997

    Report

    Report Number
    2925153-1997-00004
    Event Type
    Death
    Date Received
    March 17, 1997
    Date of Event
    February 15, 1997
    Report Date
    March 13, 1997
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PCVC CATHETER PLACED AT 1300 IN RIGHT AXILLARY VEIN WITHOUT COMPLICATIONS. X-RAY OBTAINED FOR CORRECT PLACEMENT AND CONFIRMED. FLUIDS STARTED VIA PCVC. AT APPROX. 1735 INFANT BECAME BRADYCARDIAC, CODE WAS INITIATED. INFANT WAS PRONOUNCED DEAD AT 1800.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYGM CATHETER DQO HDC CORP. 2 FR 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 31 DAY Death