BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 60 CM

    MDR report key: 3250081 · Received July 24, 2013

    Report

    Report Number
    1036844-2013-00246
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 5, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS PLACED INTO THE PATIENT IN THE OPERATING ROOM. SOMETIME AFTER PLACEMENT IN THE PT'S ROOM IT WAS NOTED THERE WAS A LEAK FROM THERE THE BLUE BOX CLAMP WAS PLACED (APPROXIMATELY 30 CM FROM THE DISTAL TIP). AS A RESULT, THE CATHETER WAS REMOVED BUT WAS NOT REPLACED BECAUSE THERE WAS NO NEED FOR FURTHER TREATMENT. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344751 CVC KIT: 3-LUMEN 7 FR X 60 CM ADULT MULTI-LUMEN CATHETER DQY ARROW INTL., INC. RF2021984

    Patients

    Seq Age Sex Outcome Treatment
    1