BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD WINGED

    MDR report key: 6124335 · Received November 23, 2016

    Report

    Report Number
    6124335
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 18, 2016
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IV CATHETER FOUND TO BE SHEARED. MANUFACTURER RESPONSE FOR IV CATHETER, INSYTE-N AUTOGUARD WINGED (PER SITE REPORTER): PREVIOUSLY REPORTED ISSUE THAT IS REOCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775460 INSYTE-N AUTOGUARD WINGED CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BD 6133854

    Patients

    Seq Age Sex Outcome Treatment
    1