BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ

    MDR report key: 1920759 · Received November 24, 2010

    Report

    Report Number
    1920759
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 29, 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

    PATIENT HAD BEEN RECEIVING TAXOTERE INFUSION FOR APPROXIMATELY 15 MINUTES WHEN HE REPORTED HIS SHIRT FELT WET. THE TUBING WAS FOUND TO BE LEAKING JUST ABOVE THE LOCATION WHERE IT WAS CONNECTED TO THE SALINE LINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *