BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3122733 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13041
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 30, 2013
    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 DEVICE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION. 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 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 ACTUAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, TWO UNUSED (COMPANION)UNITS FROM THE SAME LOT NUMBER WERE RECEIVED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. SPECIFICATION REQUIREMENTS WERE MET. THE REPORTED CONDITION WAS NOT CONFIRMED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EMPTY INTRAVIA CONTAINER WITH PVC PORT HAD PARTICULATE MATTER FOUND ON ITS PORT. THE PARTICULATE MATTER WAS OBSERVED BEFORE COMPOUNDING OF THE BAGS BEGAN. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224153 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR13C07079

    Patients

    Seq Age Sex Outcome Treatment
    1