BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI CVC KIT: 3-L FR X 20 CM AGB

    MDR report key: 4212815 · Received August 4, 2014

    Report

    Report Number
    1036844-2014-00332
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 27, 2014
    Report Date
    August 1, 2014
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SEE MDR 1036844-2014-00331 FOR THE FIRST EVENT WITH THE SAME PT. IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A FEMALE PT IN HER (B)(6) IN THE EMERGENCY ROOM. A SECOND KIT WAS OPENED AND THE CLINICIAN REPORTED THEY WERE ATTEMPTING TO INSERT THE CATHETER INTO THE PT'S RIGHT INTERNAL JUGULAR. AGAIN THEY WERE UNABLE TO THREAD THE SPRING WIRE GUIDE THROUGH THE ARROW RAULERSON SYRINGE. AT WHICH TIME EVERYTHING WAS REMOVED AND THEY FOUND THE SPRING WIRE GUIDE WAS KINKED. A THIRD KIT WAS OPENED AND WAS PLACED SUCCESSFULLY INTO THE PT'S RIGHT FEMORAL. THERE WAS A DELAY IN TREATMENT WITH NO PT HARM AND NO PT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455157 PI CVC KIT: 3-L FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC 23F14F1450

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR