BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 21546118 · Received March 7, 2025

    Report

    Report Number
    21546118
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 24, 2025
    Report Date
    February 26, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ATTEMPTED TO GIVE IV INSULIN WITH REPLACEMENT IV INSULIN SYRINGE AND SYRINGE WOULD NOT STAY INTO LEURLOCK DEVICE ON PATIENT'S IV. ADMINISTRATION OF INSULIN REQUIRED 2 RNS. 1 RN HAD TO HOLD SYRINGE INTO LEURLOCK WHILE SECOND RN PUSHED PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798212 JELCO SYRINGE, PISTON FMF SMITHS MEDICAL ASD, INC. 4319 6011601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown