BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLIT SEPTUM MICRO T-CONNECTOR

    MDR report key: 18787984 · Received February 27, 2024

    Report

    Report Number
    18787984
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 15, 2024
    Manufacturer
    HUMMINGBIRD MED DEVICES INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BEDSIDE NURSE (RN) CHANGED DIAPER AND WALKED TO OPPOSITE SIDE OF BED (MONITOR SIDE), AND THE MONITOR WAS ALARMING. THIS RN LOOKED UP AND SAW THAT THE ARTERIAL LINE TRACING WAS DAMPENED AND HAD NEGATIVE NUMBERS, AND I IMMEDIATELY LOOKED AT RIGHT GROIN AND SAW BLOOD COMING FROM ART LINE SITE. I APPLIED PRESSURE, AND IT WAS DETERMINED THAT THE HUMMI T-CONNECTOR WAS CRACKED. WITH THE FELLOW, AND ATTENDING DOCTORS AT THE BEDSIDE WE CHANGED THE T-CONNECTOR PIECE AND THE SAFE SET AND RE-DRESSED THE SITE. THERE WAS BLOOD LOSS ASSOCIATED WITH THE EVENT. THIS POSSIBLY CONTRIBUTED TO A LATER RBC BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116168 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC NMT8046

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Female Other