BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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    MDR report key: 2843704 · Received October 29, 2012

    Report

    Report Number
    2843704
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 29, 2012
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    THREE REPORTS OF LEAKING FROM IV FILTERS THAT WERE BEING USED IN IV TUBING SETUP FOR NICU PATIENTS. NO INJURY DETERMINED. THE SETS ARE SOLD BY HOSPIRA AND MANUFACTURED BY ICU MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SET, ADMINISTRATION, WITH FILTER FPA HOSPIRA, INC. 15 IN 0.88ML, SMALLBORE EXT, CLAVE, 0.2 MICRON FILTER 21-626-SJ
    2 * SET, ADMINISTRATION, WITH FILTER FPA HOSPIRA, INC. 15 IN 0.88ML, SMALLBORE EXT, CLAVE, 0.2 MICRON FILTER 17-105-JW
    3 * SET, ADMINISTRATION, WITH FILTER FPA HOSPIRA, INC. 15 IN 0.88ML, SMALLBORE EXT, CLAVE, 0.2 MICRON FILTER 21-756-SL

    Patients

    Seq Age Sex Outcome Treatment
    1 *