BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD PRIMARY PLUMSET, CLAVE, PORT CLAVE Y SITE

    MDR report key: 2915776 · Received October 31, 2012

    Report

    Report Number
    2915776
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    PRIMED THE PRIMARY PLUMSET WITH IVIG; WHEN PRIMING SET, MEDICATION STARTED RUNNING OUT THE SECONDARY CONNECTION SITE DUE TO CRACKED TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD PRIMARY PLUMSET, CLAVE, PORT CLAVE Y SITE SET, ADMINISTRATION, INTRAVASCULAR FPA HOSPIRA * 12538-28

    Patients

    Seq Age Sex Outcome Treatment
    1 *