BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ

    MDR report key: 1920762 · Received November 24, 2010

    Report

    Report Number
    1920762
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 24, 2010
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    AT THE END OF PATIENT'S IV INFUSION, IT WAS DISCOVERED THAT THERE WAS A LEAK AT THE CLAVE CONNECTION OF THE OXALIPLATIN AND THE LEUCOVORIN. SMALL WET SPOT WAS ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ IV TUBING SET FPA HOSPIRA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *