BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS KIT: 2-L 15 FR X 24 CM

    MDR report key: 2033864 · Received February 11, 2011

    Report

    Report Number
    1036844-2011-00058
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 10, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTION SITE WAS THE LEFT INTERNAL JUGULAR VEIN. THE CATHETER WOULD NOT STAY CONNECTED TO THE TUNNELER. THE CATHETER WAS REMOVED AND ANOTHER CATHETER WAS INSERTED SUCCESSFULLY INTO THE SAME INSERTION SITE. THE THERAPY WAS NOT DELAYED OR INTERRUPTED. THERE WAS NO INJURY OR COMPLICATION TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS KIT: 2-L 15 FR X 24 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. RF9086483

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR