BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2220588 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20371
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    LHI
    PMA / PMN Number
    K973654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE ACTUAL SAMPLE WAS EVALUATED. FUNCTIONAL TESTS WERE PERFORMED, AND BAXTER WAS NOT ABLE TO CONFIRM THE REPORTED CONDITION, THEREFORE NO ASSIGNABLE CAUSE WAS ABLE TO BE DETERMINED. FUNCTIONAL TESTING WAS PERFORMED TO TEST THE GENERAL FUNCTION OF THE PRODUCT AND ADEQUACY OF THE DIRECTIONS FOR USE. THE RETURNED SAMPLE FUNCTIONED AS INTENDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE TREND REVIEW OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THRU (B)(4). A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT IN ASSOCIATION WITH THIS EVENT.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO BAXTER THAT A VIAL-MATE ADAPTOR WAS LEAKING DURING FILLING ON AN UNKNOWN DATE. NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - CLEVELAND GR284844

    Patients

    Seq Age Sex Outcome Treatment
    1