BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI CVC KIT: 3-L 7 FR X 20 CM AGB

    MDR report key: 3960122 · Received June 23, 2014

    Report

    Report Number
    1036844-2014-00279
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE INTENSIVE CARE UNIT ON A (B)(6). THE PHYSICIAN ATTEMPTED TO PLACE THE CENTRAL LINE INTO THE PATIENT'S RIGHT SUBCLAVIAN. DURING REMOVAL OF THE SPRING WIRE GUIDE REMOVAL THE PHYSICIAN MET RESISTANCE AND THE WIRE BROKE. THEY IMMEDIATELY REMOVED THE CATHETER AND WIRE. THE PHYSICIAN WAS ABLE TO PULL EVERYTHING FROM THE PATIENT AS ONE. NO SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT DEVELOPED A THROMBUS FORMATION IN THE VEIN WHICH WAS SEEN UPON ULTRASOUND. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. THE LINE WAS NEEDED FOR VASOPRESSORS/HEMODYNAMIC MONITORING. THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE FOR AICD INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364782 PI CVC KIT: 3-L 7 FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL 23F14B0188

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR