BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 8 (20 CM)

    MDR report key: 2033879 · Received February 11, 2011

    Report

    Report Number
    1036844-2011-00056
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 8, 2011
    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). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEEK AFTER THE CATHETER WAS INDWELLED IN THE PT'S RIGHT SUBCLAVIAN VEIN, A LEAK AT THE INSERTION SITE WAS FOUND WHILE IN THE HOSPITAL WARD. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITHOUT ISSUE. NO ANTI-CANCER DRUG WAS USED, SALINE WAS FOUND LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 7 FR X 8 (20 CM) ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF0088345

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK