BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM

    MDR report key: 2071020 · Received April 19, 2011

    Report

    Report Number
    9610847-2011-00025
    Event Type
    Other
    Date Received
    April 19, 2011
    Report Date
    April 10, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVAL. ADD'L INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    DURING STYLET REMOVAL, THE NEEDLE/STYLET ASSEMBLY DETACHED FROM THE WHITE STYLET PULLER, CAUSING THE SAFETY MECHANISM TO FAIL AND REQUIRING THE NURSE TO USE FORCEPS TO REMOVE THE NEEDLE/STYLET FROM THE DEVICE.

    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 0222654

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK