BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 60 CM

    MDR report key: 2061536 · Received March 16, 2011

    Report

    Report Number
    1036844-2011-00093
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    December 31, 2010
    Report Date
    March 11, 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 ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PT'S ROOM, 30 DAYS AFTER THE CATHETER WAS INSERTED IN THE FEMORAL VEIN, THE PROBLEM WAS NOTED. THE CATHETER BODY WAS FOUND SEPARATED APPROX 2CM FROM THE JUNCTION HUB. THE CATHETER WAS REMOVED AND REPLACED SUCCESSFULLY. ISODINE WAS USED TO DISINFECT THE CATHETER. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS. THE PT OUTCOME WAS GOOD. ADDITIONAL INFO RECEIVED ON (B)(6) 2011 FROM TELEFLEX (B)(6) STATED, "THE CATHETER BODY WAS SEPARATED AT 2CM FROM THE JUNCTION HUB. THERE WAS NO HOLE IN IT. THE INSERTION DEPTH OF THE CATHETER WAS ABOUT 40 CM, SO ABOUT 18CM OF THE CATHETER BODY WAS OUT OF THE BODY, REMOVING THE CATHETER WAS NO PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 7 FR X 60 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. AK-17752-J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK