BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX EVA BAG

    MDR report key: 6073071 · Received November 2, 2016

    Report

    Report Number
    1419106-2016-00420
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED USED SAMPLE WAS RETURNED FOR EVALUATION. THE BATCH REVIEW FOUND NO INDICATION OF RELATED NONCONFORMANCE DURING THE MANUFACTURE OF THIS PRODUCT. THE VISUAL INSPECTION IDENTIFIED THE REPORTED ISSUE AS A LOOSE PARTICULATE MATTER WITHIN THE BAG, DIRECTLY ABOVE THE ADMINISTRATION PORT. MAGNIFIED INSPECTION OF THE REMOVED PARTICULATE MATTER IDENTIFIED THE PM AS A SMALL, GRAY PARTICLE WITH POROUS MATERIAL, RESEMBLING PACKING FOAM. A REVIEW OF THE MANUFACTURING PROCESS FOUND NO AREA OF THE PROCESS IN WHICH THE PARTICULATE COULD HAVE ORIGINATED. BASED ON EVALUATION FINDINGS, THE ROOT CAUSE OF WHERE THE PARTICULATE ORIGINATED IS UNKNOWN. 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 HAVE GRAY PARTICULATE ON THE LOWER AREA OF THE BAG. THE PARTICULATE WAS DISCOVERED DURING PHARMACY INSPECTION. NO PATIENT INVOLVEMENT OR ADVERSE EVENTS OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724322 EXACTAMIX EVA BAG EVA TPN BAG KPE BAXTER HEALTHCARE CORPORATION 740 1144588

    Patients

    Seq Age Sex Outcome Treatment
    1