BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4173789 · Received August 7, 2014

    Report

    Report Number
    1036844-2014-00337
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 4, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S SUBCLAVIAN VEIN IN THE INTENSIVE CARE UNIT. THEY DID NOT USE THE RAULERSON SYRINGE. DURING INSERTION THE SPRING WIRE GUIDE KINKED. AS A RESULT, ANOTHER KIT WAS OPENED. SEE MDR 1036844-2014-00338 FOR THE SECOND KIT USED WITH THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464943 PI CVC KIT: 3-L 7 FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 23F14C1151

    Patients

    Seq Age Sex Outcome Treatment
    1