BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4212806 · Received August 4, 2014

    Report

    Report Number
    1036844-2014-00331
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 27, 2014
    Report Date
    July 30, 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

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A FEMALE PT IN HER (B)(6) IN THE EMERGENCY ROOM. THE CLINICIAN REPORTED THEY WERE INSERTING THE CATHETER INTO THE PT'S LEFT INTERNAL JUGULAR. THEY WERE UNABLE TO THREAD THE SPRING SIRE GUIDE THROUGH THE ARROW RAULERSON SYRINGE. AT WHICH TIME EVERYTHING WAS REMOVED AND THEY FOUND THE SPRING WIRE GUIDE WAS KINKED. A SECOND KIT WAS OPENED. SEE MDR 1036844-2014-00332 FOR THE SECOND EVENT WITH THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455156 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