BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN/PSI KIT

    MDR report key: 1645805 · Received March 19, 2010

    Report

    Report Number
    3006425876-2010-00018
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 19, 2010
    Manufacturer
    ARROW INTL INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON A RIGHT JUGULAR INSERTION SITE, THE USER CONNECTED THE 3-WAY STOPCOCK TO THE CENTRAL VENOUS CATHETER (CVC). THE DIFFICULTY WAS ENCOUNTERED A FEW HOURS AFTER INSERTION OF THE CATHETER. PROPOFOL WAS APPLIED TO THE PT. DUE TO DROPS THAT APPEARED IN THE STOPCOCK, LEAKING STARTED AT THE SIDE CONNECTION OF THE STOPCOCK. AS A RESULT, THE USER CONNECTED A COMPETITOR'S 3-WAY STOPCOCK SUCCESSFULLY TO THE CATHETER. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN/PSI KIT CRITICAL CARE PSI PRODUCTS KGZ ARROW INTL INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PROPOFOL