BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    HUMMI MICRO-DRAW

    MDR report key: 16291419 · Received February 3, 2023

    Report

    Report Number
    16291419
    Event Type
    No answer provided
    Date Received
    February 3, 2023
    Date of Event
    January 15, 2023
    Report Date
    January 24, 2022
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    KST
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HUMMI CENTRAL LINE BLOOD DRAWING DEVICE WITH LOT# 22228 FOUND TO BE CRACKED AT THE JOINING OF THE WASTE AND SAMPLE CLEAR PORTION OF THE DEVICE. THIS WAS NOTICED WHILE PERFORMING A CENTRAL LINE BLOOD DRAW ON THE NEONATE VIA UVC AND FINDING AIR BUBBLES COMING FROM THIS CRACK AND FILLING MY BLOOD SAMPLE WITH AIR. OTHER DEVICES WITH SAME LOT NUMBER WERE CHECKED AND THE MAJORITY OF THAT LOT FOUND TO BE CRACKED. DIFFERENT LOT NUMBERS WERE INSPECTED AND FOUND TO NOT BE CRACKED. POOR PRODUCT MANUFACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400935 HUMMI MICRO-DRAW SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL KST KENTEC MEDICAL, INC. ABG-HM-1 22228

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Unknown