BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DIPOSABLE

    MDR report key: 3122907 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13069
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED A BLACK PARTICULATE MATTER IN THE FLUID PATH. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE EMPTY GAMMA STERILIZED 500 ML INTRAVIA CONTAINER WAS FOUND TO HAVE BLACK PARTICULATE MATTER IN THE ADMINISTRATION PORT DURING ADMIXTURE AND PRIOR TO PATIENT USE. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224948 IVT DIPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR131B04094

    Patients

    Seq Age Sex Outcome Treatment
    1