BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV SAFETY IV CATHETER

    MDR report key: 2140478 · Received June 23, 2011

    Report

    Report Number
    2140478
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 15, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE INSERTED A 20G IV USING THE PROTECTIV PLUS CATHETER ON THE PATIENT. THE NURSE THEN ENGAGED THE SAFETY ON THE CATHETER. THE SAFETY DEVICE APPEARED TO HAVE ENACTED, MOVING THE NEEDLE INTO THE DEVICE. THE NURSE WENT TO PROPERLY DISPOSE OF THE SHARP AND THE NEEDLE HAD BROKEN UP THROUGH THE DEVICE CAUSING INJURY TO THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIV SAFETY IV CATHETER IV CATHETER FOZ SMITHS MEDICAL 3066 2014-01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR