BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV SAFETY IV CATHETER

    MDR report key: 2140476 · Received June 23, 2011

    Report

    Report Number
    2140476
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 16, 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 WAS ATTEMPTING TO INSERT A 22G PROTECTIV IV CATHETER INTO THE PATIENT. AFTER INSERTION, THE NEEDLE WOULD NOT FULLY RETRACT AND THE NURSE HAD TO REMOVE THE ENTIRE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIV SAFETY IV CATHETER IV CATHETER FOZ SMITHS MEDICAL 3060 ST1891949

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR