BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2252223 · Received September 16, 2011

    Report

    Report Number
    6000001-2011-25327
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WAS RETURNED BY THE CUSTOMER FOR EVALUATION. ADDITIONAL INFORMATION: THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ONE (1) EMPTY INTRAVIA CONTAINER IN WHICH A FILAMENT WAS DETECTED IN THE BAG ON AN BEFORE PATIENT USE. REPORTER STATED THAT A SIMILAR EVENT WAS REPORTED ONE YEAR AGO. NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR11F13171

    Patients

    Seq Age Sex Outcome Treatment
    1