BEUDAMED
    FDA Adverse Event Death Summary report: N

    VYGM

    MDR report key: 72679 · Received February 27, 1997

    Report

    Report Number
    72679
    Event Type
    Death
    Date Received
    February 27, 1997
    Date of Event
    February 15, 1997
    Report Date
    February 24, 1997
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PCVC CATHETER PLACED @1300 IN R AXILLARY VEIN WITHOUT COMPLICATIONS. X-RAY OBTAINED FOR CORRECT PLACEMENT AND CONFIRMED. FLUIDS STARTED VIA PCVC. AT APPROX. 1735 INFANT BECAME BRADYCARDIC, CODE WAS INITIATED. INFANT WAS PRONOUNCED DEAD AT 1810.

    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