BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS CAREFUSION SMARTSITE

    MDR report key: 3021283 · Received March 20, 2013

    Report

    Report Number
    3021283
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CARDINAL HEALTH, ALARIS PRODUCTS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    IV TEAM IN TO PLACE PIV (PERIPHERAL IV) AND DRAW LABS. AFTER BLOOD DRAWN FROM T-CONNECTOR AND SYRINGE REMOVED, NOTED PLUNGER IN ENDCAP (SMARTSITE CAP) NOT POPPING BACK OUT TO SEAL. IMMEDIATELY REMOVED AND REPLACED WITH NEW ENDCAP. NO PATIENT HARM. THIS IS THE 5TH REPORTED EVENT WITH THIS PRODUCT IN THE LAST TWO MONTHS AT THIS FACILITY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BLOOD DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116179 ALARIS CAREFUSION SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CARDINAL HEALTH, ALARIS PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR NO OTHER THERAPIES