BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3240098 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19261
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 28, 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 BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 150 ML INTRAVIA CONTAINER HAD CLEAR PLASTIC PARTICULATE MATTER INSIDE THE BAG. THIS EVENT WAS DISCOVERED AFTER THE BAG WAS FILLED, PRIOR TO USE ON A PATIENT. THEREFORE THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339789 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR13C07079

    Patients

    Seq Age Sex Outcome Treatment
    1