BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMI MICRO-DRAW

    MDR report key: 18788348 · Received February 23, 2024

    Report

    Report Number
    MW5152009
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 21, 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

    PERIPHERAL ARTERIAL LINE BEGAN TO SPRAY BLOOD ON INFANT. DURING INSPECTION - HUMMI DEVICE NOTICED TO BE CRACKED AT THE JOINING SECTION OF THE CLEAR PORTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926895 HUMMI MICRO-DRAW SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL KST KENTEC MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 DA Male