BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED NITRO SET PVC TBG SEGMENT INJ SITE L/L ADPT

    MDR report key: 1852455 · Received October 4, 2010

    Report

    Report Number
    6000001-2010-03722
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 6, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K832285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION AND THE REPORTED CONDITION WAS CONFIRMED THROUGH THE VISUAL INSPECTION. BATCH RECORDS WERE ALSO REVIEWED AND NO DEVIATIONS WERE FOUND. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE SPIKE WAS RECEIVED FROM A SUPPLIER AND WILL BE NOTIFIED IN ORDER TO PERFORM AN INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION BUT IS STILL PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED UPON ITS COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT THE SPIKE OF THE VENTED NITRO SET BROKE EASILY WHEN ATTEMPTING TO PLACE IN THE GLASS. PATIENT INJURY AND MEDICAL INTERVENTION WERE NOT REPORTED FOR THIS EVENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED NITRO SET PVC TBG SEGMENT INJ SITE L/L ADPT PUMP, INFUSION FPA BAXTER HEALTHCARE R10D20065

    Patients

    Seq Age Sex Outcome Treatment
    1