BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX EVA BAG

    MDR report key: 6045791 · Received October 20, 2016

    Report

    Report Number
    1419106-2016-00404
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED SAMPLE WAS RETURNED FOR EVALUATION. THE VISUAL AND FUNCTIONAL TEST DID NOT FIND ANY LEAKAGE ON THE BAG. ALL CONNECTORS AND PORTS WERE FOUND UNDAMAGED AND NOT LOOSE. THE REPORTED CONDITION WAS NOT CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION OF THE PROVIDED SAMPLE IS ANTICIPATED, BUT NOT YET BEGUN. THE BATCH REVIEW DID NOT FIND ANY NONCONFORMANCES RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TPN THERAPY BAG WAS FOUND TO HAVE A LOOSE CONNECTOR. THE ISSUE WAS DISCOVERED BEFORE THE COMPOUNDING PROCESS. THIS REPORT DOCUMENTS NO PATIENT INVOLVEMENT OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696848 EXACTAMIX EVA BAG EVA TPN BAG KPE BAXTER HEALTHCARE CORPORATION 741 1054843

    Patients

    Seq Age Sex Outcome Treatment
    1