BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD

    MDR report key: 3780684 · Received April 23, 2014

    Report

    Report Number
    MW5035811
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 18, 2014
    Manufacturer
    HOSPIRA INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SECONDARY CLAVE PORT BROKE WHILE PREPARING FLUID PRIMING. MEDICATION LEAKED FROM PORT. INSPECTION OF ADD'L UNOPENED SETS IDENTIFIED BREAKS IN TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245249 LIFESHIELD PLUM SET PRIMARY FPA HOSPIRA INC. 12538-28 36-013-5H;38059-58

    Patients

    Seq Age Sex Outcome Treatment
    1