BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA-MED ORAL DISPENSERS 0.5ML/1ML/3ML/5ML

    MDR report key: 813888 · Received February 7, 2007

    Report

    Report Number
    MW1041901
    Event Type
    Malfunction
    Date Received
    February 7, 2007
    Date of Event
    December 6, 2006
    Report Date
    February 7, 2007
    Manufacturer
    BAXA CORPORATION
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXA CORPORATION'S EXACTA-MED ORAL DISPENSERS HAVE AN INADEQUATE SEAL ACHIEVED BY THE TIP CAP RESULTING IN THE EVAPORATION OF THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MED ORAL DISPENSERS 0.5ML/1ML/3ML/5ML ORAL SYRINGES KYX BAXA CORPORATION H938 *
    2 EXACTA-MED ORAL DISPENSERS 0.5ML/1ML/3ML/5ML ORAL SYRINGES KYX BAXA CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *