BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 14 GA X 8"

    MDR report key: 3250243 · Received July 24, 2013

    Report

    Report Number
    9680794-2013-00046
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 18, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K820009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WEEK AFTER THE CATHETER WAS PLACED IN THE PATIENT'S FEMORAL VEIN, A LEAK WAS FOUND NEAR THE JUNCTION HUB. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. THE MEDICAL SOLUTION USED WAS HICALIQ NEOAMIYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346228 CVC SET: 14 GA X 8" SINGLE LUMEN CVC PRODUCTS DQY ARROW INTERNATIONAL INC. CF2021292

    Patients

    Seq Age Sex Outcome Treatment
    1