BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2300831 · Received October 19, 2011

    Report

    Report Number
    6000001-2011-31967
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    October 1, 2011
    Report Date
    October 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE HENCE THE ROOT CAUSE CANNOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN FROM THE INVESTIGATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED BAXTER CORPORATE PRODUCT SURVEILLANCE A 250ML INTRAVIA EMPTY CONTAINER IN WHICH PARTICULATE MATTER WAS FOUND. ACCORDING TO THE REPORT, THE CONTAINER HAD A PIECE OF BAXA TUBING FLOWED INTO THE BAG DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR11E10146

    Patients

    Seq Age Sex Outcome Treatment
    1