BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIAL (SOL-M) BLUNT FILL NEEDLE

    MDR report key: 16529418 · Received March 10, 2023

    Report

    Report Number
    MW5115669
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 9, 2023
    Manufacturer
    SOL-MILLENNIAL MEDICAL, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CORED PIECE OF THE MEDICATION VIAL STOPPER WAS FOUND IN THE REMAINING MEDICATION SOLUTION LEFT IN THE VIAL ITSELF OR ONCE DRAWN INTO A SYRINGE PRIOR TO INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836017 SOL-MILLENNIAL (SOL-M) BLUNT FILL NEEDLE SET, I.V. FLUID TRANSFER LHI SOL-MILLENNIAL MEDICAL, INC. 110022 05203024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown