BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK VALVE 2 VERSASAFE NEEDLE-FREE INJECTION PORTS

    MDR report key: 1870799 · Received October 2, 2010

    Report

    Report Number
    1870799
    Event Type
    Malfunction
    Date Received
    October 2, 2010
    Date of Event
    August 24, 2010
    Report Date
    October 2, 2010
    Manufacturer
    ALARIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE NOTICED THE PORT IN THE NEW IV TUBING HAD A HOLE IN IT. SAVED TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHECK VALVE 2 VERSASAFE NEEDLE-FREE INJECTION PORTS IV TUBING FPA ALARIS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR