BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VPS BEDSIDE KIT

    MDR report key: 3021036 · Received March 20, 2013

    Report

    Report Number
    3006795936-2013-00005
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 19, 2013
    Manufacturer
    VASONOVA
    Product Code
    OBJ
    PMA / PMN Number
    K103255
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS PLACED WITH THE USE OF THE VPS INTO THE PT'S ARM. WHEN THE NURSE ATTEMPTED TO REMOVE THE STYLET FROM THE DOUBLE LUMEN NAVILYST PICC THEY ENCOUNTERED RESISTANCE AND THE STYLET SEPARATED. THE STYLET AND CATHETER WERE REMOVED AS ONE AND ANOTHER CATHETER WAS PLACED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115607 VASONOVA VPS BEDSIDE KIT CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA V1207010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NAVILYST PICC