BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMI CONNECTOR PIECE

    MDR report key: 18788367 · Received February 23, 2024

    Report

    Report Number
    MW5152010
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 21, 2024
    Manufacturer
    HUMMINGBIRD MED DEVICES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CRACK NOTED ON THE TUBING NEAR THE HUMI PORT. PAL WAS NOT BEING MANIPULATED AT THE TIME OF THE EVENT (T-PIECE CONNECTOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926896 HUMMI CONNECTOR PIECE SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES, INC. NMT8046

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Male