BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAF-T-INTIMA

    MDR report key: 275038 · Received April 21, 2000

    Report

    Report Number
    MW1018735
    Event Type
    Other
    Date Received
    April 21, 2000
    Date of Event
    April 19, 2000
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IV STAFF WENT TO OPEN PACKAGE AND FOUND IT TO BE GROSSLY DEFECTIVE, IE: STYLETTE PIERCING THROUGH CATHETER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T-INTIMA IV CATHETER 20 GA FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other