BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 15 FR X 28 CM

    MDR report key: 1203528 · Received October 17, 2008

    Report

    Report Number
    1036844-2008-00206
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    July 15, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MSD
    PMA / PMN Number
    K010399
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE CANNON CATHETER WAS IMPLANTED VIA RIGHT INTERNAL JUGULAR VEIN IN 2006 WITHOUT EVENT. IN 2008, A LEAK WAS DETECTED IN THE RED ARTERIAL LINE OF THE EXTERNAL CONNECTION. WHEN THE USER OBSERVED THE LEAK, IT WAS DISCOVERED THAT ONLY THE HUB CONNECTION ASSEMBLY (CAR) NEEDED TO BE EXCHANGED. AS A RESULT, AFTER THE EXCHANGE OF THE EXTERNAL CONNECTION (CAR) THE PT FOLLOWED WITH NORMAL DIALYSIS. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 15 FR X 28 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTERNATIONAL INC. RL5111241

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR