BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUPLEX CEFTRIAXONE DRUG DELIVERY SYSTEM

    MDR report key: 3972796 · Received July 25, 2014

    Report

    Report Number
    MW5037520
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 25, 2014
    Manufacturer
    B BRAUN
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    UPON RECONSTITUTION, A SMALL AMOUNT OF SOLUTION SQUIRTED OUT OF BAG/PORT AND WENT INTO PATIENT'S EYES. NO HARM TO PATIENT WAS EVIDENT. EYE WAS FLUSHED WITH WATER AS RECOMMENDED BY MANUFACTURER. DOSE AMOUNT: ROCEPHIN 1GM; FREQUENCY: DAILY; ROUTE: IV DUPLEX. DIAGNOSIS OR REASON FOR USE: EMPIRIC TX - VTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436713 DUPLEX CEFTRIAXONE DRUG DELIVERY SYSTEM DUPLEX FPA B BRAUN H4B707

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR