BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 1900694 · Received November 11, 2010

    Report

    Report Number
    1900694
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF HAVE EXPRESSED CONCERN THAT DUE TO THE SIZE OF THE SYRINGE AND THE LINE AND ML MARKINGS "OVERLAPPING" THERE IS POTENTIAL RISK FOR OVERDOSING, PARTICULARLY WITH BOTOX INJECTIONS THAT ARE GIVEN IN NEUROLOGY.PER THE NURSE:WHEN DRAWING UP ANY CLEAR LIQUID WITH THE SYRINGE, THE WRITING ON THE BACK SIDE OF THE SYRINGE MAKES IT DIFFICULT TO SEE EXACTLY HOW MUCH IS IN THE SYRINGE. THE DR ALSO TOLD ME THAT IT IS HARD TO SEE WHEN ADMINISTERING, ESPECIALLY WHEN INJECTING SMALL VOLUMES TYPICALLY DELIVERED BY THIS SYRINGE. WE USE THESE SYRINGES TO GIVE BOTOX, WHICH IS GIVEN IN VERY SMALL INCREMENTS (SOMETIMES DOWN TO THE TENTH OR HUNDREDTH OF AN ML). WHEN THE WORDING ON THE BACK OBSCURES THE VIEW OF THE LINES ON THE SYRINGE, IT MAKES IT VERY DIFFICULT FOR THE MD TO MAKE SURE THAT THEY ARE GIVING THE CORRECT VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUER-LOK SYRINGE FMF BD 309628 9261913

    Patients

    Seq Age Sex Outcome Treatment
    1 *