BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUNT TIP NEEDLE

    MDR report key: 21573786 · Received March 11, 2025

    Report

    Report Number
    MW5167484
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 6, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE DREW UP A VIAL OF MIDAZOLAM, AND WHEN ACCESSING WITH A BLUNT TIP NEEDLE A PIECE OF THE TOP WENT INTO THE SOLUTION. CORING EVENT OCCURRED. BLUNT TIP NEEDLE LOT NUMBER: 240630, MADE BY SOL-MILLENNIUM MEDICAL, INC. MIDAZOLAM LOT NUMBER: 024055, MADE BY HIMKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228302 BLUNT TIP NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SOL-MILLENNIUM MEDICAL, INC. 240630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MIDAZOLAM.