BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 GAUGE NEEDLE

    MDR report key: 19158605 · Received April 22, 2024

    Report

    Report Number
    19158605
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    April 16, 2024
    Report Date
    April 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT COMPLAINED OF PAIN WITH BLOOD DRAW. PHLEBOTOMIST STATED THAT IT FELT "ROUGH" WITH ACCESS AND DEACCESS. WHEN CLOSING NEEDLE GUARD, IT BROKE. NEEDLE EXAMINED UNDER MICROSCOPE NOTED TO HAVE FRAYED METAL ON THE END. PT CALLED BACK AFTER LEAVING STATING ARM HURT, HE WAS ADVISED TO RETURN TO ED. HE WAS ON HIS WAY TO WORK. AT THIS TIME HE HAS NOT RETURNED TO ED. THIS NEEDLE WAS LAST IN BOX. PACKAGING NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686214 21 GAUGE NEEDLE 21 GAUGE NEEDLE FMI BECTON DICKINSON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male
    1 47 YR Male