BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    84" ADMINISTRATION SET

    MDR report key: 1860284 · Received September 22, 2010

    Report

    Report Number
    2245270-2010-00011
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 22, 2010
    Manufacturer
    VYGON
    Product Code
    FPA
    PMA / PMN Number
    K011336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY RESULTS OF INVESTIGATION POINTS TO USER ERROR TYPICALLY SEEN WITH EITHER INCORRECT OR NO PRIMING PRIOR TO USE OR SHAKING OF THE SET PRIOR TO USE. HOWEVER, THE DEVICE SAMPLES WERE SENT TO THE SUPPLIER OF THE FILTER FOR FURTHER INVESTIGATION. RESULTS OF INVESTIGATION AND ANY REMEDIAL ACTIONS TAKEN (I.E. RE-TRAINING) WILL BE SENT IN A FOLLOW UP MDR.

    Description of Event or Problem · 1

    AIR IS PASSING THROUGH FILTER OF IV ADMINISTRATION SET WHEN ADMINISTERING FLUID. NO INJURY OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 84" ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA VYGON AMS 292-2 1006074

    Patients

    Seq Age Sex Outcome Treatment
    1