BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7FR X 30CM

    MDR report key: 4212786 · Received August 4, 2014

    Report

    Report Number
    3006425876-2014-00164
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT OCCURRED IN THE ICU. DURING INSERTION INTO THE FEMALE PATIENT'S SUBCLAVIAN VEIN, THE PUNCTURE NEEDLE BROKE AT THE HUB. AS A RESULT, THE BROKEN NEEDLE WAS REMOVED, COMPLETELY INTACT, AND A NEW SET WAS OPENED AND USED TO SUCCESSFULLY PROCEED. THERE WAS A DELAY REPORTED; HOWEVER, THERE WAS NO HARM TO THE PATIENT. THERE WERE NO COMPLICATIONS, DEATH, OR INJURY REPORTED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455191 CVC KIT: 3-LUMEN 7FR X 30CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 71F14B0550

    Patients

    Seq Age Sex Outcome Treatment
    1