BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAF-T-INTIMA SHIELED IV CATHETER

    MDR report key: 1023633 · Received April 1, 2008

    Report

    Report Number
    9610847-2008-00026
    Event Type
    Other
    Date Received
    April 1, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED FROM THE CUSTOMER. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE REMOVING THE SAF-T-INTIMA CATHETER, THE CANNULA BENT AND TWISTED. THE CATHETER BROKE, LEAVING ABOUT 15 MM IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T-INTIMA SHIELED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 7158073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK