BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONIN SYSTEM

    MDR report key: 3960043 · Received May 29, 2014

    Report

    Report Number
    3006795936-2014-00010
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED IN THE PERIPHERAL VEIN OF THE PATIENT AT THE BEDSIDE IN THE PERIPHERAL VEIN OF THE PATIENT AT THE BEDSIDE IN THE INTENSIVE CARE UNIT. DURING INSERTION THEY RECEIVED A BLUE BULLS EYE ON TH VPS AND THE PICC WAS ONLY IN THE VESSEL 10CM. AS A RESULT, THE CATHETER WAS PLACED WITHOUT THE USE OF 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
    315925 VASCULAR POSITIONIN SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1