BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP

    MDR report key: 2065906 · Received April 18, 2011

    Report

    Report Number
    2065906
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    January 3, 2011
    Report Date
    April 18, 2011
    Manufacturer
    APP PHARMACEUTICALS, LLC
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS GIVEN 60 MG OF DECADRON IV INSTEAD OF 12 MG. IT WAS ORDERED 12 MG OF DECADRON EVERY 8 HOURS FOR ASTHMA EXACERBATION. THE LABEL OF THE IV DECADRON BOTTLE (IN THE HIGHLIGHTED AREA) READ 4 MG/ML, BUT ON THE BOTTOM OF THE LABEL IN SMALLER LETTERS IT READ "5 ML MULTIPLE DOSE VIAL. THE NURSE CHECKED THE DOSE ON THE BOTTLE 3 TIMES AND SAW 4 MG. SHE GAVE 3 BOTTLES FOR A TOTAL OF 60 MG/15MLS. THE NURSING STAFF AS WELL AS THE PHARMACY FEEL THAT THE LABELING ON THIS BOTTLE IS CONFUSING AND COULD LEAD OTHER HEALTH CARE PROVIDERS TO MAKE THE SAME MISTAKE. THE NURSE WOULD LIKE TO SEE 20MG/5ML IN THE HIGHLIGHTED LABEL SECTION INSTEAD OF 4MG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP MEDICATION BOTTLE KYX APP PHARMACEUTICALS, LLC * 205318

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR