BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS TWO-LUMEN K IT: 2-L 28 FR

    MDR report key: 2102936 · Received May 4, 2011

    Report

    Report Number
    1036844-2011-00140
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    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 THAT THE CATHETER WAS PLACED IN A PT AT THE HOSPITAL ON (B)(6) 2011. THE PT HAS BEEN RECEIVING SUCCESSFUL DIALYSIS SINCE THEN AND RECENTLY IT WAS NOTED THAT THERE WAS A CRACK IN THE BLUE INJECTION HUB OF THE CATHETER. THE CRACK ONLY BECAME EVIDENT ONCE INJECTION PRESSURE WAS EXERTED ON THE PORT. THE EXTERNAL CATHETER HUB WAS SUCCESSFULLY REMOVED AND REPLACED WITH A CANNON REPAIR KIT, CAR 02800. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS TWO-LUMEN K IT: 2-L 28 FR CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK