BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL DISPENSER

    MDR report key: 1545668 · Received November 19, 2009

    Report

    Report Number
    MW5013653
    Event Type
    Malfunction
    Date Received
    November 19, 2009
    Report Date
    November 19, 2009
    Manufacturer
    NEOMED INC
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE ORAL SYRINGES/DISPENSERS MFG BY NEOMED DO NOT SAY "FOR ORAL USE ONLY" ANYWHERE ON THE SYRINGE. THE 6 ML SYRINGE IS CALIBRATED IN 0.25 ML INCREMENTS; WHEREAS, OTHER 5-6 ML ORAL SYRINGES ARE CALIBRATED IN 0.2 ML INCREMENTS. WE FEEL THAT THESE ISSUES COULD LEAD TO POTENTIAL DOSING/ADMINISTRATION ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL DISPENSER ORAL SYRINGE, 1, 3, 6, 12, 20, 35, AND 61 ML KYX NEOMED INC

    Patients

    Seq Age Sex Outcome Treatment
    1