BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM AND PRINTER

    MDR report key: 3205473 · Received June 28, 2013

    Report

    Report Number
    3006795936-2013-00018
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 28, 2013
    Manufacturer
    VASONOVA
    Product Code
    OBJ
    PMA / PMN Number
    K103260
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PICC TEAM REC'D A BLUE BULLSEYE WITH 7 CM OUT COMING FROM THE RIGHT. IT WAS READ BY RADIOLOGY AS BEING AT THE BRACHIAL CEPHALIC. THEY WERE TOLD TO RE-GUIDE THE CATHETER IN 6 CM. THIS WAS DONE USING THEIR SHRLOCK AND IT WAS READ AT THE CAJ. THERE WAS NO DELAY IN THERAPY AND NO PT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295099 VASCULAR POSITIONING SYSTEM AND PRINTER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK