BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS KIT: 2-L 15 FR X 28 CM

    MDR report key: 2945136 · Received January 31, 2013

    Report

    Report Number
    1036844-2013-00043
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED BY ANOTHER CUSTOMER, CLINIQUE, ON (B)(6) 2012, THEN TRANSFERRED TO THE DIALYSIS CENTER. A LEAK FROM THE EXTENSION LINES OF THE CATHETER PLACED IN THE PT'S RIGHT INTERNAL JUGULAR WAS FOUND. AS A RESULT, THE CATHETER WAS REMOVED (B)(6) 2013 AND REPLACED WITH A NEW CATHETER WITHOUT ISSUE. AT THIS TIME THERE ARE NO ADDITIONAL DETAILS AS TO WHERE THE CATHETER LEAK WAS FOUND AND IF MULTIPLE LINES WERE LEAKING. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42296 HEMODIALYSIS KIT: 2-L 15 FR X 28 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. RF1083007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK