BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 1104440 · Received August 4, 2008

    Report

    Report Number
    1710034-2008-00091
    Event Type
    Malfunction
    Date Received
    August 4, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED 10 REPRESENTATIVE UNITS FOR THE INVESTIGATION. OUR QUALITY ENGINEER PERFORMED A PULL-STRENGTH TEST ON EACH OF THE RETURNED UNITS AND CONFIRMED THAT THE EXTENSION TUBING SEPARATED FROM THE Y-ADAPTER FOR ONE OF THE UNITS. THE DEVICE HISTORY WAS REVIEWED FOR THE REPORTED LOT NUMBER 8070431 AND NO IRREGULARITIES WERE NOTED DURING THE LOT'S MANUFACTURE. CONCLUSIONS: THE ENGINEER CONCLUDED THAT VISUAL AND MICROSCOPIC INSPECTIONS SHOWED A LACK OF GLUE INSIDE THE Y-ADAPTER WHERE THE EXTENSION TUBING SITS. THIS TYPE OF DEFECT IS MANUFACTURING RELATED AND CAPA (B) (4) WAS OPENED ON 04-28-2008 TO ELIMINATE THIS EXTENSION TUBE FAILURE. (B) (4)

    Description of Event or Problem · 1

    THE EXTENSION TUBING SEPARATED FROM THE BD NEXIVA ADAPTER. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD NEXIVA CLOSED IV ACCESS SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 8070431

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR