BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMI MICRO DRAW T-CONNECTOR

    MDR report key: 18960202 · Received March 21, 2024

    Report

    Report Number
    MW5153056
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    March 14, 2024
    Report Date
    March 19, 2024
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    KST
    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

    BEDSIDE RN (REGISTERED NURSE) REASSESSED PAL AND NOTICE THE LINE WAS SPLIT NEAREST THE T CONNECTOR. THE HUMMI T CONNECTOR WAS REPLACED, FLUSHED, ASPIRATED, AND RE-SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408832 HUMMI MICRO DRAW T-CONNECTOR SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL KST KENTEC MEDICAL, INC. NMT8046 583009

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA Female