BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2033910 · Received February 11, 2011

    Report

    Report Number
    1036844-2011-00052
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 7, 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 ONE DAY AFTER THE CATHETER WAS INDWELLED, A LEAK FROM THE STOPCOCK WAS NOTICED WHILE IN THE HOSPITAL WARD. AS A RESULT, ONLY THE STOPCOCK WAS REPLACED WITH A NEW ONE. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 8 (20 CM) ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF0075051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK