BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 GAUGE BLUNT FILL HYPO NEEDLE

    MDR report key: 18858077 · Received March 6, 2024

    Report

    Report Number
    MW5152457
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Report Date
    March 4, 2024
    Manufacturer
    SOL-MILLENNIUM MEDICA, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN THE SOL-M BLUNT FILL NEEDLE IS USED TO PUNCTURE MEDICATION VIALS, IT CAN CORE OUT THE RUBBER AND PUSH IT INTO THE MEDICATION VIAL, THUS CONTAMINATING THE VIAL. POTENTIAL FOR DRAWING THE PIECE OF RUBBER BACK INTO THE SYRINGE AND INJECTING INTO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160789 18 GAUGE BLUNT FILL HYPO NEEDLE SET, I.V. FLUID TRANSFER LHI SOL-MILLENNIUM MEDICA, INC. 110022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown