BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 8.5FR X 20CM

    MDR report key: 3249787 · Received July 23, 2013

    Report

    Report Number
    3006425876-2013-00125
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLUE FIXING CLAMP DOES NOT HOLD THE CATHETER TIGHT AND THE CATHETER SLIPS OUT OF THE CLAMP. THE EVENT OCCURRED IN THE KMT 11 OST OF THE HOSPITAL. THE CATHETER WAS REMOVED AND REPLACED BEFORE IT SLIPPED OUT OF THE PATIENT IT IS UNKNOWN IF THERE WAS A DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342310 CVC KIT: 3-LUMEN 8.5FR X 20CM ADULT MULTI-LUMEN CATHETER DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1