BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLIT SEPTUM MICRO T-CONNECTOR

    MDR report key: 10459646 · Received August 27, 2020

    Report

    Report Number
    10459646
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 6, 2020
    Report Date
    August 17, 2020
    Manufacturer
    HUMMINGBIRD MED
    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

    RN NOTED THAT HUMMI 6" MINIBORE EXTENSION SET WITH SPLIT TUBING CRACKED CLOSE TO 1.5-2CM AWAY FROM HUMMI HUB, NOTED TO HAVE SMALL AMOUNT OF BLOOD LEAKING DUE TO BLOOD BACKING UP. NNP (NEONATAL NURSE PRACTITIONER) AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923593 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED NMT8046 1923

    Patients

    Seq Age Sex Outcome Treatment
    1 90 DA