BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMED ORAL SYRINGES

    MDR report key: 1755833 · Received June 18, 2010

    Report

    Report Number
    MW5016668
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 18, 2010
    Manufacturer
    EXACTAMED
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS PER OUR HOSPITAL PROCEDURE, PATIENT RECEIVED CLEAR SYRINGES -EXACTAMED FROM BAXA- WITH THE BLACK MARKS ON THE LINE OF THE SYRINGE WHERE THE CAREGIVERS WERE TO DRAW UP THE ORAL MEDICATION. THE LINE WAS APPROPRIATELY DELINEATED ON THE "TIC" MARK FOR 3.75 ML; HOWEVER, THE LINE CROSSED THE NUMBER "4" WHICH WAS DELINEATED TO THE SIDE OF THE TIC MARKS. IN FACT, THE NUMBERS DENOTING MILLILITERS 1, 2, 3, 4, AND 5 DID NOT CORRESPOND TO THE APPROPRIATE "TIC" MARKS ON THE SYRINGE. THE FATHER BROUGHT THIS TO OUR ATTENTION AND NEW SYRINGES FROM ANOTHER COMPANY WERE GIVEN TO HIM. THERE WAS NO ADVERSE OUTCOME TO THIS PATIENT. DIAGNOSIS OR REASON FOR USE: MEDICATION ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMED ORAL SYRINGES 5 ML KYX EXACTAMED

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR