BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRAVASCULAR

    MDR report key: 20270280 · Received September 19, 2024

    Report

    Report Number
    MW5159827
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    September 13, 2024
    Report Date
    September 17, 2024
    Manufacturer
    MEDLINE, INDUSTRIES, LP - NORTHFIELD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALL PHLEBOTOMIST WORKING THIS MORNING DOING AM LABS IN SOUTH TOWER AND NORTH TOWER, HAD ISSUES WITH THE MEDLINE 25 GAUGE ORANGE BUTTERFLY. MEDLINE 25 GAUGE BUTTERFLYS LOT # 240501-1. THESE BUTTERFLIES ARE MALFUCTIONING. WHEN YOU STICK PATIENT BLOOD IS COMING OUT SO SLOW AND WHEN YOU PUT SECOND TUBE ON VEINS ARE BLOWING DUE TO THE FACT THAT NO BLOOD IS EVEN DRIPPING IN THE SECOND TUBE. I USED A 3MM SYRINGE ON THE TUBING AND PULLED BACK NO BLOOD COMES OUT OF TUBING ON MULTIPLE PATIENTS. ALSO, THERE WAS 8 PHLEBOTOMIST WORKING ON MORNING RUN AND WITH SAME ISSUES. THIS EFFECTS RUN DRAWS AND IS A PATIENT SAFETY ISSUE ALSO. THESE NEEDLES ARE NOT OF GOOD QUALITY AND IS CAUSING PATIENTS TO BE STUCK MULTIPLE TIMES AND EFFCTING PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525653 SET, ADMINISTRATION, INTRAVASCULAR SET, ADMINISTRATION, INTRAVASCULAR FPA MEDLINE, INDUSTRIES, LP - NORTHFIELD 240501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown