BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3113333 · Received April 29, 2013

    Report

    Report Number
    3113333
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 29, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    CRACK NOTED AT END ADAPTOR SITE ON T-CONNECTOR. RN WENT TO FLUSH AND SOLUTION SQUIRTED OUT. CONNECTOR CHANGED AND REST OF LACTATED RINGERS SOLUTION INFUSED WITHOUT INCIDENT. NO HARM TO THE PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185347 * SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR