BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 14078016 · Received April 11, 2022

    Report

    Report Number
    1451040-2022-00013
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 11, 2022
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NURSE EXPERIENCED A NEEDLE COMPLETELY BENDING WHILE PREPARING A VARICELLA VACCINE. THE NEEDLE SUBSEQUENTLY DISLODGED AND FELL ON THE FLOOR. NO INFORMATION WAS RECEIVED REGARDING ANY TYPE OF SERIOUS INJURY AS A RESULT OF THIS PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12271 MCKESSON BRANDS NEEDLE, SAFETY PREVENT HT 25GX5/8" FMI SOL-MILLENNIUM MEDICAL INC. CS0J10-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other