BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER

    MDR report key: 2985304 · Received April 17, 2007

    Report

    Report Number
    9610847-2007-00101
    Event Type
    Malfunction
    Date Received
    April 17, 2007
    Date of Event
    February 1, 2007
    Report Date
    April 16, 2007
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEM
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FIFTEEN UNUSED UNITS FROM THE REPORTED LOT NUMBER 6240029 WERE REC'D ON (B)(4) 2007 AND ARE CURRENTLY UNDER INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AFTER REMOVAL OF THE STYLET, THE TUBING SNAPPED OFF AT THE ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SAF-T-INTIMA IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEM NA 6240029

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR