BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2136730 · Received June 9, 2011

    Report

    Report Number
    2136730
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    TUBING SPONTANEOUSLY DISCONNECTED AT THE DISTAL END OF Y-SITE FROM NEEDLE FREE VALVE PORT ON BROVIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INTRAVASCULAR TUBING FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 *