BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3143196 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14118
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. ONE UNIT WAS RECEIVED FOR EVALUATION AGAINST THE REPORTED CONDITION OF PARTICULATE MATTER INSIDE OF THE FLUID PATHWAY. VISUAL INSPECTION WAS PERFORMED UPON RECEIPT OF THE SAMPLE. NO FUNCTIONAL TESTING WAS PERFORMED. WHITE PARTICULATE MATTER WAS OBSERVED, CONFIRMING THE REPORTED CONDITION. THE CAUSE WAS DETERMINED TO BE THE MANUFACTURING PROCESS OF THE INTERNAL SUPPLIER AS THE PARTICULATE MATTER WAS RELATED TO THE TUBING CUT PROCESS AFTER DEVICE ASSEMBLY. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAVIA CONTAINER HAD PARTICULATE MATTER WITHIN THE FLUID PATH. THE DEVICE WAS BEING FILLED WITH RECONSTITUTED PROLASTIN-C. REPORTEDLY, A 60 ML BD SYRINGE WAS USED TO RECONSTITUTE THE PROLASTIN-C VIALS WITH A SUPPLIED DILUENT. AFTER RECONSTITUTION, THE PROLASTIN-C WAS TRANSFERRED TO THE INTRAVIA BAG VIA A FILTERED NEEDLE. UPON TRANSFER, A 2-3 MM LONG, STRAND SHAPED PARTICLE, WAS NOTED IN THE BAG. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244806 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR10L07181

    Patients

    Seq Age Sex Outcome Treatment
    1