BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE CGC ADULT INFUSION

    MDR report key: 3703208 · Received March 11, 2014

    Report

    Report Number
    3703208
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    January 15, 2014
    Report Date
    February 28, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    IV TUBING WOULD NOT STAY ATTACHED TO NEEDLELESS CONNECTION ATTACHED TO PATIENT. NEEDLELESS CONNECTOR CHANGED AND TUBING STILL WOULD NOT STAY ATTACHED. CHANGED IV TUBING AND CONNECTION STAYED ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146286 SMARTSITE CGC ADULT INFUSION SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR