BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1964102 · Received January 11, 2011

    Report

    Report Number
    1710034-2010-00067
    Event Type
    Other
    Date Received
    January 11, 2011
    Date of Event
    August 2, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVAL. ADD'L INFO HAS BEEN REQUESTED REGARDING THIS INCIDENT. UPON COMPLETION OF THE NO SAMPLE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE CLINICIAN WAS UNABLE TO RETRACT THE NEEDLE AS THE BUTTON DID NOT WORK. THIS RESULTED IN A NEEDLESTICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other