BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD PRIMARY PIGGYBACK SET NV

    MDR report key: 614702 · Received July 26, 2004

    Report

    Report Number
    9613251-2004-00103
    Event Type
    Malfunction
    Date Received
    July 26, 2004
    Date of Event
    June 28, 2004
    Report Date
    June 29, 2004
    Manufacturer
    HOSPIRA LTD./ABBOTT LTD
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM AN INTERNATIONAL AFFILIATE OF THE Y-CLAVE HOUSING SEPERATED FROM THE Y COMPONENT. THE EVENT OCCURED IN THE EMERGENCY DEPARTMENT. IT WAS REPORTED THAT THE BLUE CLAVE PORTION OF THE PORT SEPERATED FROM THE CLEAR Y-SITE. THE CONTACT WAS UNABLE TO DETERMINE WHICH OF THE THREE PORTS ON THE SET HAD SEPERATED. THE CONTACT BELIEVED THAT THE SEPERATION OCCURRED AHILE A SECONDARY SET WAS BEING CONNECTED TO THE PRIMARY SET VIA THE CLAVE PORT. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD PRIMARY PIGGYBACK SET NV ADMINISTRATION SET FPA HOSPIRA LTD./ABBOTT LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other