BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA (TM) 4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK

    MDR report key: 2021470 · Received March 7, 2011

    Report

    Report Number
    2021470
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STOPCOCK ON DOUBLE LUMEN UAC PORT #2 (WHERE TPN AND LIPIDS INFUSE) CRACKED AND ALLOWED ARTERIAL BLOOD TO BACK UP, AND LEAK OUT ONTO BABY'S BEDS/SHEETS/DIAPER. THIS PORT IS NOT THE TRANSDUCED PORT, SO NO PRESSURE "LOSS" WAS SENSED, AND NO ALARM WOULD BE AUDIBLE. RN NOTED LARGE VOLUME OF BLOOD ON BABY'S BED WHEN PLACING FEEDING SYRINGE NEXT TO BABY. THE NEONATOLOGIST'S NOTE INDICATES THE BABY LOST APPROXIMATELY 10ML OF BLOOD. THE HEMOGRAM THAT WAS DRAWN THE NEXT DAY SHOWS IT WENT DOWN; HOWEVER, NO NEW ORDERS WERE RECEIVED FOR BLOOD. THE NEWBORN WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA (TM) 4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK STOPCOCK FMG SMITHS MEDICAL MX2341L 1798973

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DAY