BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC SAFETY NEEDLE 19GX1"

    MDR report key: 14756655 · Received June 17, 2022

    Report

    Report Number
    MW5110406
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 16, 2022
    Manufacturer
    COVIDIEN / CARDINAL HEALTH 200, LLC.
    Product Code
    FMI
    UDI-DI
    8881850910
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) MEDICAL CENTER USED MAGELLAN HYPODERMIC SAFETY NEEDLES 19G X 1" ITEM # 8881850910 LOT # 201820 IN PREPARATION OF PATIENT MEDICATIONS. UPON OPENING PRODUCT, TECHNICIAN NOTED CONTAMINATION IN THE HUB OF THE NEEDLE AND DISCONTINUED USE WITHOUT PATIENT EXPOSURE. SURVEY OF PHARMACY AND HOSPITAL REVEAL NO FURTHER ITEMS WITH THIS LOT ON BOARD. BECAUSE OF DELAY IN REPORTING, NO TESTING INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141138 HYPODERMIC SAFETY NEEDLE 19GX1" NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN / CARDINAL HEALTH 200, LLC. 201820 8881850910

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown