BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER

    MDR report key: 938876 · Received April 17, 2007

    Report

    Report Number
    9610847-2007-00040
    Event Type
    Malfunction
    Date Received
    April 17, 2007
    Date of Event
    March 1, 2007
    Report Date
    April 16, 2007
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TWELVE UNUSED UNITS FROM THE REPORTED LOT NUMBER 6240029 WERE RECEIVED ON 09 APRIL 2007 AND ARE CURRENTLY UNDER INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE TUBING IS SNAPPING OFF AT THE ADAPTER DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SAF-T-INTIMA IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 6240029

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR