BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA SHIELDED IV CATHETER

    MDR report key: 1436340 · Received May 14, 2009

    Report

    Report Number
    9610847-2009-00022
    Event Type
    Malfunction
    Date Received
    May 14, 2009
    Date of Event
    February 11, 2009
    Report Date
    April 15, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS CURRENTLY UNDER INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    DURING INSERTION, THE TUBING SEPARATED FROM THE ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T-INTIMA SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 6178202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK