BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2000 ML LINER W/ VAC-GUARD

    MDR report key: 1032008 · Received April 21, 2008

    Report

    Report Number
    1713468-2008-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 26, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    GCX
    PMA / PMN Number
    K893741
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE DOMESTIC LIST NUMBER THAT IS COMPARABLE TO THE INTERNATIONAL LIST NUMBER IN THE "OTHER "FIELD.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO SUCTION. PRIOR TO PT USE, DURING THE TESTING OF THE SUCTION SET UP, THE HEALTHCARE PROFESSIONAL NOTED NO SUCTION. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2000 ML LINER W/ VAC-GUARD 79-GCX GCX HOSPIRA, INC. NA 43254YJ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA