BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4-WAY STOPCOCK

    MDR report key: 17879 · Received October 17, 1994

    Report

    Report Number
    17879
    Event Type
    Injury
    Date Received
    October 17, 1994
    Date of Event
    October 12, 1994
    Report Date
    October 14, 1994
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FMG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN WALKED PAST CRIB AND OBSERVED BLOOD "SPURTING" FROM STOPCOCK ON ARTERIAL UMBILICAL LINE. STOPCOCK IMMEDIATELY TURNED OFF TO BABY AND REPLACED. INFANT'S VITAL SIGNS AND OXYGEN SATURATION STAYED WITHIN NORMAL LIMITS. HGB/HCT CHECKED, TRANSFUSION REQUIRED. THIS STOPCOCK IN LINE FOR 11.75 HOURS. PREVIOUS STOPCOCK WITH SMALL CRACK (NOT SAVED) WITHOUT LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4-WAY STOPCOCK 4-WAY STOPCOCK FMG PHARMASEAL DIV. BAXTER HEALTHCARE CORP. 643391

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DAY Life Threatening| R USUAL FOR NEWBORN IN NICU