BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNON II PLUS REPLACEMENT HUB SET

    MDR report key: 2932294 · Received January 22, 2013

    Report

    Report Number
    1036844-2013-00022
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 22, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 THE PROCEDURE WAS BEING PERFORMED IN THE DIALYSIS DEPARTMENT. THE CONNECTORS ARE TEARING/RUPTURING DURING USE. AS A RESULT, A NEW REPAIR KIT WAS USED TO CORRECT THE ISSUE. ON (B)(6) 2013 - FOLLOW UP INFORMATION CONFIRMS THE LUER HUBS ARE CRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31490 CANNON II PLUS REPLACEMENT HUB SET CHRONIC HEMODIALYSIS CATHETER PRODUCTS NFK ARROW INTERNATIONAL INC RF9096856

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK