BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 7 FR X 60 CM

    MDR report key: 3013207 · Received March 15, 2013

    Report

    Report Number
    1036844-2013-00086
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    K854137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A (B)(6). THE CATHETER WAS PLACED INTO THE PATIENT'S LEFT BASILIC VEIN. AFTER ONE WEEK OF USE, THE LUER HUB SEPARATED FROM THE EXTENSION LINE. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER THAT WAS INSERTED FEMORALLY. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110896 CVC SET: 2-LUMEN 7 FR X 60 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR