BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REP LACEMENT SET

    MDR report key: 2061515 · Received March 16, 2011

    Report

    Report Number
    1036844-2011-00094
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNON CATHETER WAS INSERTED ON (B)(6) 2011 AT A HOSPITAL. THE INSERTION LOCATION WAS THE PT'S LEFT SUBCLAVIAN VEIN. WHILE AT ANOTHER HOSPITAL, IN THE RENAL CARE UNIT, THE PT WAS IN BEGINNING HER DIALYSIS TREATMENT WHEN THE PIGTAIL ON THE CANNON CATHETER STARTED TO LEAK. IT WAS NOTED THAT THERE WAS A CRACK ON THE PIGTAIL. AS A RESULT, THE PT COULD NOT BE DIALYZED UNTIL THE CANNON WAS REPAIRED. THERE WAS A DELAY IN DIALYSIS AND THE HARM TO THE PT WAS RECORDED AS "INCREASED BLOOD RESULTS - PT IS IN RENAL FAILURE." THE SCHEDULED DIALYSIS WAS CANCELLED AND THE PT RECEIVED HER DIALYSIS AFTER THE REPAIR. THERE WAS NO REPORTED PT DEATH OR INJURY. INTERVENTION WAS REQUIRED AND NOTED AS "REPAIR OF PIGTAIL ON CANNON CATHETER." THERE WERE NO REPORTED PT COMPLICATIONS. THE OUTCOME IS LISTED AS SUCCESSFULLY DIALYZED AND SENT HOME AFTER USING THE REPAIR KIT FOR THE CANNON CATHETER. REFERENCE MDR #1036844-2011-00095 FOR ANOTHER REPORT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2-L HUB CONNECT ASSY REP LACEMENT SET CHRONIC HEMODIALYSIS CATHETER PRODUCTS NFK ARROW INTL., INC. RF0092313

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HEPARIN 5000U