BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX EVA BAG

    MDR report key: 4962173 · Received August 3, 2015

    Report

    Report Number
    1419106-2015-00153
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Report Date
    August 4, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. THE BATCH REVIEW FOUND NO INDICATION OF RELATED NONCONFORMANCE DURING THE MANUFACTURE OF THIS PRODUCT. THE VISUAL INSPECTION IDENTIFIED MILD EVA FRAYING, WHICH WAS DETERMINED TO HAVE BEEN CAUSED BY THE MANUFACTURING PROCESS. FUNCTIONAL TESTING CONFIRMED THE REPORTED CONDITION. MANUFACTURING CONTROLS ARE IN PLACE TO REDUCE THE LIKELIHOOD OF RECURRENCE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TPN THERAPY BAG WAS FOUND TO BE LEAKING FROM THE SEAM, NEAR THE ADDITIVE PORT. WHERE IN THE PROCESS THE LEAK WAS DISCOVERED IS UNKNOWN; HOWEVER, THE REPORT DOCUMENTS NO PATIENT INVOLVEMENT OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505926 EXACTAMIX EVA BAG EVA TPN BAG KPE BAXTER HEALTHCARE CORPORATION 740 1032186

    Patients

    Seq Age Sex Outcome Treatment
    1