BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROBORE EXTENSION SET

    MDR report key: 2073513 · Received April 14, 2011

    Report

    Report Number
    2073513
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 14, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    NURSE NOTED BLOOD BACKING UP INTO IV FILTER AND BLOOD AND IV FLIUD LEAKING OUT OF FILTER'S BLUE PORT (PORT WAS NOT IN USE AND WAS NOT DEPRESSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACROBORE EXTENSION SET INTRAVASCULAR TUBING FPA HOSPIRA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY NO OTHER THERAPIES