BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 15 FR X 27 CM

    MDR report key: 2192822 · Received July 20, 2011

    Report

    Report Number
    1036844-2011-00238
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040666
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS MALE PT WAS IN END STAGE RENAL FAILURE. DURING DIALYSIS IN THE RENAL UNIT APPROX ONE MONTH AGO, THE VENOUS PORT WAS FOUND CRACKED AND FOR FOUR WEEKS USED ONLY ONE PORT TO DIALYSE. THE CATHETER WAS PLACED IN THE PT'S LEFT SUBCLAVIAN VEIN APPROX TWO MONTHS PRIOR TO THIS OCCURRENCE. AS A RESULT, THE PT HAD THE PIGTAILS REPLACED AND WILL HAVE THE NEXT DIALYSIS WITH THE DUAL METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 15 FR X 27 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. RF9097798

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK