BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAF-T-INTIMA SHIELDED IV CATHETER

    MDR report key: 1376626 · Received May 6, 2009

    Report

    Report Number
    9610847-2009-00029
    Event Type
    Other
    Date Received
    May 6, 2009
    Date of Event
    March 15, 2009
    Report Date
    April 10, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THE NEEDLE DID NOT SHIELD PROPERLY AND A NEEDLE STICK INJURY OCCURRED.

    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 6297490

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other