BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION SMARTSITE LOW SORBING INFUSION SET

    MDR report key: 3893888 · Received June 18, 2014

    Report

    Report Number
    MW5036793
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 13, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE PREPARING TO RUN CHEMO THROUGH INFUSION PUMP - NOTED LEAKING WHERE TUBING MEETS CONNECTOR AT THE TOP. DISCONTINUED BEFORE STARTED. SOME CHEMO MEDICATION LEAKED TO NURSE'S TOP WHICH WAS QUICKLY CLEANED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358953 CAREFUSION SMARTSITE LOW SORBING INFUSION SET IV TUBING WITH CONNECTOR FPA CAREFUSION CORPORATION 10061661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA