BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAF-T-INTIMA SHIELDED IV CATHETER

    MDR report key: 1239165 · Received November 19, 2008

    Report

    Report Number
    9610847-2008-00082
    Event Type
    Other
    Date Received
    November 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE TRYING TO OBTAIN A SAMPLE FOR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    THE HOSPITAL CLAIMS THAT SPECIFIC PTS ON THREE UNITS EXPERIENCED REDNESS FOLLOWED BY FEVER AND CELLULITIS SINCE THE HOSPITAL MOVED FROM THE SAFETY LOK BLOOD COLLECTION SET TO THE BD SAF-T-INTIMA FOR SUBQ PROCEDURES. THEY HAVE RULED OUT ANY OTHER POSSIBILITIES. THE DOCTORS HAVE REQUESTED REMOVAL OF THE SAF-T-INTIMA FROM THE CART AND A RETURN TO THE SLBCSET. THE EDUCATOR ADVISES THIS IS NOT SATISFACTORY AND HAS REQUESTED MORE NURSING TRAINING ON THE PRODUCT. INFECTION CONTROLS ARE NOW INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T-INTIMA SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 8182689

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other