BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLIT SEPTUM MICRO T-CONNECTOR

    MDR report key: 10157394 · Received June 16, 2020

    Report

    Report Number
    10157394
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 2, 2020
    Manufacturer
    HUMMINGBIRD MED DEVICES INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BLOOD WAS BACKING OUT OF THE RED LUMEN ON PICC LINE, NOTICED BLOOD DRIPPING OUTSIDE OF THE HUMMI TUBING. PATIENT HAS A DOUBLE LUMEN RIGHT UPPER LEG PICC, THE RED LUMEN HAS A HUMMI ATTACHED FOR LAB DRAWS. THE LINE WAS FLUSHED AND FLUID LEAKED OUT OF THE HUMMI TUBING. THE HUMMI WAS CHANGED OUT USING STERILE PROCEDURE AND FLUSHED TO CLEAR OUT THE LINE. HUMMI WAS SAVED IN A BIOHAZARD BAG AND MARKED WITH THE LOCATION OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623950 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC NMT8046 19039

    Patients

    Seq Age Sex Outcome Treatment
    1 90 DA