BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMI MICRO-DRAW

    MDR report key: 16223365 · Received January 23, 2023

    Report

    Report Number
    16223365
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    January 7, 2023
    Report Date
    January 18, 2023
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    KST
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USING A HUMMI MICRO-DRAW BLOOD TRANSFER DEVICE, FOR USE WITH SPLIT SEPCTUM MICRO T-CONNECTOR, TO DRAW LABS FROM AN UMBILICAL VENOUS CATHETER. WHEN SWITCHING SYRINGES TO COLLECT MULTIPLE BLOOD SAMPLES, HEALTHCARE PROVIDER CLAMPED THE SAMPLE LINE AND PULLED SYRINGE OFF AND BLOOD WAS STILL SLOWLY COMING BACK OUT OF THE LINE. HEALTHCARE PROVIDER QUICKLY PUT NEXT SYRINGE ON AND IT FILLED WITHOUT UNDOING CLAMP. HEALTHCARE PROVIDER EXAMINED CLAMP WITH RESPIRATORY THERAPIST (RT) AND REGISTERED NURSE (RN). HEALTHCARE PROVIDERS VERIFIED THAT IT WAS CLAMPED BUT APPEARED LOOSE. HEALTHCARE PROVIDER THEN PUT THEIR WASTE SYRINGE BACK INTO BABY AND PULLED HUMMI OUT OF LINE. IT WAS A SHARP AND HAD BLOOD IN IT SO HEALTHCARE PROVIDER PUT IT IN THE SHARPS CONTAINER. HEALTHCARE PROVIDER ESTIMATES A BLOOD LOSS OF 0.25-0.5MLS OF BLOOD FROM EVENT. BABY WEIGHS 4KG AND BLOOD LOSS DID NOT HAVE A SIGNIFICANT IMPACT ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430780 HUMMI MICRO-DRAW SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL KST KENTEC MEDICAL, INC. ABG-HM-1 22025

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Male