BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAF-T-INTIMA SHIELDED IV CATHETER

    MDR report key: 1047425 · Received May 13, 2008

    Report

    Report Number
    9610847-2008-00048
    Event Type
    Other
    Date Received
    May 13, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED FROM THE CUSTOMER. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 5/12/08.

    Description of Event or Problem · 1

    UPON INSERTION THE 20 GAUGE SAF-T-INTIMA, THE TUBING OF THE SAF-T-INTIMA SEPARATED FROM BEHIND THE WINGS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK