BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM

    MDR report key: 5474436 · Received March 2, 2016

    Report

    Report Number
    3003898360-2016-00233
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    February 25, 2016
    Report Date
    February 25, 2016
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PLACEMENT, THE CLINICIAN HAD GOOD WAVEFORM AND DOPPLER SIGNAL. A BLUE BULLS EYE WAS ACHIEVED AND A CHEST X-RAY WAS PERFORMED. THE X-RAY SHOWED THE TIP 4CM DEEP REQUIRING RETRACTION FOR OPTIMAL PLACEMENT IN THE CAJ. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129772 VASCULAR POSITIONING SYSTEM VPS G4 SYSTEM OBJ

    Patients

    Seq Age Sex Outcome Treatment
    1