BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT IV SAFETY IV CATHETER

    MDR report key: 1358382 · Received April 8, 2009

    Report

    Report Number
    MW5010664
    Event Type
    Malfunction
    Date Received
    April 8, 2009
    Date of Event
    March 25, 2009
    Report Date
    March 31, 2009
    Manufacturer
    SMITH'S MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    I.V. INITIATED WITH "PROTECT IV SAFETY IV CATHETER" IN 2009. BLOOD WAS WITHDRAWN THROUGH THE CATHETER FOR LAB WORK. WHILE REMOVING THE SYRINGE FROM THE CATHETER, THE ENTIRE LENGTH OF THE CATHETER BROKE AT THE HUB. ENOUGH OF THE CATHETER REMAINED OUTSIDE OF THE INSERTION SITE OF THE SKIN TO ALLOW FOR IMMEDIATE REMOVAL WITH THE NURSES'S FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECT IV SAFETY IV CATHETER IV ANGIOCATH FOZ SMITH'S MEDICAL JELCO REFERENCE #3053

    Patients

    Seq Age Sex Outcome Treatment
    1 26 MO