BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 4013677 · Received August 15, 2014

    Report

    Report Number
    1416980-2014-26757
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER STATED THAT THE PARTICLE APPEARED TO BE A PIECE OF PLASTIC. THE SOLUTION THAT THE BAG WAS FILLED WITH WAS COMPOUNDED FLUOROURACIL, AND THE PARTICLE WAS NOTICED WHEN MIXING THE DRUG INSIDE OF THE BAG. EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE IDENTIFIED PARTICULATE MATTER FLOATING IN THE FLUID INSIDE OF THE BAG. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE CAUSE OR ORIGIN OF THE PARTICLE IS UNDETERMINED AT THIS TIME. IN ORDER TO FURTHER INVESTIGATE THIS CONDITION AND ITS CAUSE, A CAPA WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED INSIDE AN INTRAVIA 150ML EMPTY CONTAINER. THE PARTICULATE MATTER WAS SAID TO BE 1CM IN LENGTH AND "CLOUDY" IN COLOR. THE CONTAINER WAS FILLED WITH FLUOROURACIL. THIS OBSERVATION WAS MADE AFTER THE CONTAINER WAS FILLED AND PRIOR TO PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489868 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR13I06144

    Patients

    Seq Age Sex Outcome Treatment
    1