BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3000ML EVA BAG

    MDR report key: 1872653 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04134
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT YET BEEN RECEIVED FOR OUR EVALUATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE SAMPLE IS RETURNED AND EVALUATED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. THIS INCIDENT IS BEING REPORTED BECAUSE THE PRODUCT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER ASIA PACIFIC ON (B)(6), 2010 AN INCIDENT WHERE A BAG WAS LEAKING FROM THE PORT JUNCTION WITH THE 3000 ML EVA BAG. THIS INCIDENT OCCURRED BEFORE USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3000ML EVA BAG CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 09I04V865

    Patients

    Seq Age Sex Outcome Treatment
    1