BEUDAMED
    FDA Adverse Event Summary report: N

    SPLIT SEPTUM MICRO T-CONNECTOR

    MDR report key: 11257821 · Received February 1, 2021

    Report

    Report Number
    11257821
    Date Received
    February 1, 2021
    Date of Event
    November 24, 2020
    Report Date
    January 19, 2021
    Manufacturer
    HUMMINGBIRD MED DEVICES INC
    Product Code
    FPA
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LEAKED AT JOINT IN HUMMI TUBING. ASSESSED LINE WITH OFF GOING RN IN EVENING, NO PROBLEMS NOTED. ASSESSED PATIENT 1 HOUR LATER, NO PROBLEMS NOTED. INFANT BECAME FUSSY (IS NORMALLY A FUSSY BABY), AND ANOTHER NURSE WAS CALLED TO THE ROOM TO COMFORT HIM WHILE I WAS BUSY WITH MY OTHER BABY. AFTER A FEW MINUTES, THE RN NOTED FRESH SPOTS OF BLOOD APPEARING ON BEDDING THAT WERE NOT THERE BEFORE AND FRANK BLOOD BACKING UP IN THE RED LUMEN OF THE DOUBLE LUMEN PICC LINE. LINE WAS FLUSHED WITH NS BUT BLOOD RETURNED ALMOST IMMEDIATELY AND WAS VISIBLY LEAKING FROM THE HUB OF THE HUMMI DEVICE ATTACHED TO THE END OF THE PICC LINE. HUMMI HAD NOT BEEN USED FOR BLOOD DRAWS SINCE INFANT HAS BEEN IN THIS UNIT. HUMMI WAS REMOVED FROM PICC LINE AND A T-PIECE PUT ON IN ITS PLACE WHEN THE LINE WAS CHANGED SHORTLY THEREAFTER. THE DEVICE WAS SENT TO MANUFACTURER. THIS IS ALL INFORMATION AVAILABLE ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154425 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC NMT 8046 19293

    Patients

    Seq Age Sex Outcome Treatment
    1 60 DA