BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM

    MDR report key: 3815336 · Received March 27, 2014

    Report

    Report Number
    3006795936-2014-00005
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER CONTROL NO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE (B)(4) CATHETER WAS BEING PLACED INTO THE PATIENT'S ARM IN THEIR ROOM. DURING INSERTION, THE CONSOLE DISPLAYED A BLUE BULLSEYE BUT THE CATHETER TIP WAS STILL IN THE VASCULAR OUTSIDE THE SVC. THE NURSE WAS STILL APPROXIMATELY 8 TO 10CM OUT FROM THE CAJ. THE BLUE BULLSEYE WENT AWAY AND THE RN CONTINUED TO INSERT THE CATHETER AND REACHED THE LOWER 1/3 WHERE HE RECEIVED ANOTHER BLUE BULLSEYE. AN X-RAY WAS PERFORMED TO CONFIRM TIP LOCATION WHICH CORRELATED WITH THE VPS. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181810 VASCULAR POSITIONING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 LUMEN 5 FR X 50 CM WITH PRELOADED VPS STYLET| ARROW PRESSURE INJECTABLE PICC 2| (B)(4)