BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 16 GA X 8 (20 CM)

    MDR report key: 2934858 · Received January 23, 2013

    Report

    Report Number
    1036844-2013-00024
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K820009
    Removal / Correction Number
    NA
    Adverse Event
    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 ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PATIENT'S ROOM, A WEEK AFTER THE CATHETER WAS PLACED IN THE PATIENT'S INTERNAL JUGULAR VEIN, A LEAK WAS FOUND FROM THE EXTENSION LINE NEAR THE INJECTION HUB. AS A RESULT, THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32978 CVC KIT: 16 GA X 8 (20 CM) ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RM2083973

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK