BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLIT SEPTUM MICRO T-CONNECTOR

    MDR report key: 22175580 · Received June 10, 2025

    Report

    Report Number
    22175580
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 19, 2025
    Report Date
    May 28, 2025
    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

    1) [DATE REDACTED] PATIENT 1. THE MICRO T-CONNECTOR OF THE HUMMI DEVICE ON THE PATIENT'S ARTERIAL LINE CRACKED AND CAME APART AT THE CONNECTION SITE OF THE T-CONNECTOR (SO THERE WAS NO PLACE TO CLAMP THE LINE IN ORDER TO STOP THE BLEEDING). DUE TO OUR INABILITY TO CLAMP THE T-CONNECTOR, WE HELD PRESSURE ON THE ARTERIAL INSERTION SITE AND THEN ULTIMATELY REMOVED THE LINE COMPLETELY. ONCE THE LINE WAS REMOVED AND PRESSURE WAS HELD ON THE SITE FOR ABOUT 5 MINUTES, THE BLEEDING STOPPED. 2) [DATE REDACTED] PATIENT 2. THE MOM WAS HOLDING THE PATIENT WHEN THE NURSE (RN) NOTICED THE ARTERIAL WAVEFORM DAMPENING. RN WENT TO THE BEDSIDE TO CHECK ON THE ARTERIAL LINE. THE MOM ASKED TO HELP PUT PATIENT BACK IN BED. RN PULLED OFF BLANKET AND NOTICED A POOL OF BLOOD - UPON INSPECTION WITH A SECOND RN, DRESSING WAS STILL INTACT BUT THERE APPEARED TO BE A CRACK ON THE HUMMI T-CONNECTOR WHERE BLOOD WAS DRIPPING. THE PROVIDER CAME IN QUICKLY TO ASSIST IN CHANGING OUT THE T-PIECE WHICH RESOLVED THE BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633430 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC NMT8046

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Female