BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMI TRANSFER DEVICE

    MDR report key: 9488616 · Received December 18, 2019

    Report

    Report Number
    9488616
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    October 20, 2019
    Report Date
    December 2, 2019
    Manufacturer
    HUMMINGBIRD MED DEVICES INC
    Product Code
    KST
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER REPORT FROM THE NICU RN, DURING AN ARTERIAL BLOOD GAS BEING DRAWN WITH THE HUMMI TRANSFER DEVICE, DURING THE WASTE PORTION, THE BLOOD LEAKED "EVERYWHERE." THE TUBING UP BY THE HUB WAS SEVERED. THE RN WAS ABLE TO CLAMP OFF THE TUBING. THERE WAS NO HARM TO THE INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284122 HUMMI TRANSFER DEVICE SYSTEM, BLOOD COLLECTION KST HUMMINGBIRD MED DEVICES INC

    Patients

    Seq Age Sex Outcome Treatment
    1