BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 8 (20CM)

    MDR report key: 3032974 · Received April 1, 2013

    Report

    Report Number
    2242445-2013-00036
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 31, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PATIENT'S ROOM A MONTH AFTER THE CATHETER WAS PLACED IN THE PATIENT'S INTERNAL JUGULAR VEIN, A LEAK WAS FOUND NEAR THE BLUE CLAMP PLACED 14-15CM FROM THE DISTAL TIP. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. NOTE: THE SALES REP EXPLAINED TO THE USER THAT THE CATHETER SHOULD BE PLACED NO LONGER THAN 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131739 CVC KIT: 3-LUMEN 7 FR X 8 (20CM) ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. MF1115943

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK