BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV SAFETY IV CATHETER

    MDR report key: 2140474 · Received June 23, 2011

    Report

    Report Number
    2140474
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    April 17, 2011
    Report Date
    June 21, 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 INSERTING A 24G PROTECTIV IV CATHETER INTO THE PATIENT'S FINGER. DURING THE IV ATTEMPT, THE NEEDLE BROKE THROUGH THE PLASTIC CATHETER SHEATH, STICKING THE PATIENT'S FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIV SAFETY IV CATHETER IV CATHETER FOZ SMITHS MEDICAL 3063 ST17885804

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR