BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2212455 · Received July 29, 2011

    Report

    Report Number
    2212455
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    B. BRAUN MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    THE SAFETY DEVICE FAILED TO ENGAGE ON THE IV NEEDLE/SMITHS MEDICAL CATHLON IV CATHETER BEING USED BY THE NURSE RESULTING IN A NEEDLE STICK TO THE NURSE. THE APPROPRIATE POST EXPOSURE PROTOCOL WAS FOLLOWED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY IV CATHETER FOZ B. BRAUN MEDICAL 20 G IC17258271

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES