BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REP LACEMENT SET

    MDR report key: 2061535 · Received March 16, 2011

    Report

    Report Number
    1036844-2011-00095
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 14, 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). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    REFERENCE MDR # 1036844-2011-00094 FOR A REPORTED EVENT INVOLVING THE SAME PT. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE PT HAD THE SAME ISSUE A FEW WEEKS AGO. THE INCIDENT WAS NEVER REPORTED TO THE SALES REP UNTIL 03/09/2011. THE CANNON CATHETER WAS INSERTED ON (B)(6) 2011 AT A HOSPITAL. THE INSERTION LOCATION IS THE PT'S LEFT SUBCLAVIAN VEIN. ON (B)(6) 2011, IT WAS NOTED THAT THERE WAS A CRACK ON THE PIGTAIL. AS A RESULT, THE CANNON WAS REPAIRED. 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.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK