BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM

    MDR report key: 2120289 · Received June 1, 2011

    Report

    Report Number
    9610847-2011-00037
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INTERNAL FILE NUMBER: (B)(4). DATE SUBMITTED: (B)(4) 2011.

    Description of Event or Problem · 1

    TWENTY-FOUR HOURS AFTER INSERTION, THE EXTENSION TUBING SEPARATED FROM THE ADAPTER WHILE THE PT WAS WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 0195861

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other