BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 2 0 CM

    MDR report key: 3030973 · Received March 28, 2013

    Report

    Report Number
    3006425876-2013-00038
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ARROW INTERNATIONAL 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). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PT'S ROOM A TIME AFTER PLACING THE CATHETER IN THE PT'S RIGHT INTERNAL JUGULAR VEIN, THE DISTAL INJECTION HUB WAS FOUND DETACHED FROM THE EXTENSION LINE. AS A RESULT OF THIS OCCURRENCE, AIR WAS FOUND INSIDE THE PT'S RIGHT ATRIUM. THE CATHETER WAS REMOVED AND NOT REPLACED AND THE OPERATION ENDED. NO ADDITIONAL INTERVENTION WAS NEEDED AFTER THE USER IS MONITORING THE PT'S CONDITION, HOWEVER, THERE SEEMS TO BE NO PROBLEM." THERE WAS NO REPORTED DELAY OR DEATH AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129520 CVC KIT: 2-LUMEN 7 FR X 2 0 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC ZF2109800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK