BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLYBOOK CONSOLE WITH PRINTER

    MDR report key: 3899079 · Received May 16, 2014

    Report

    Report Number
    3006795936-2014-00009
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K103260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO.: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE CATHETER WAS BEING PLACED INTO THE PT'S RIGHT ARM IN THEIR ROOM. THE CLINICIAN STARTED TO INSERT THE STYLET AND GOT A BLUE BULLS EYE, HOWEVER, THEY HAD ONLY ADVANCED THE CATHETER 7CM. AT WHICH TIME, THE BLUE BULLS EYE SYMBOL WENT AWAY AND CHANGED TO A GREEN ARROW SYMBOL. THEY COULD NOT ADVANCE THE STYLET FURTHER THAN 15CM. THEY REMOVED THE STYLET AND TRIED AGAIN A FEW MORE TIMES. THEY WERE UNSUCCESSFUL WITH THE PROCEDURE. THEY WERE UNABLE TO FIND A GOOD VEIN TO PLACE A CATHETER. THERE WAS DELAY IN TREATMENT WITH NO PT HARM AND NO PT DEATH OR COMPLICATIONS REPORTED. IT WAS NOTED THE LOT NUMBER FOR THE STYLET IS UNK AND THE STYLET WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294061 FLYBOOK CONSOLE WITH PRINTER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1