BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 6830597 · Received August 30, 2017

    Report

    Report Number
    6830597
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    July 10, 2017
    Report Date
    August 1, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RN OPENED IV INSYTE CANNULA PACKAGE AND NOTED INSYTE CANNULA WAS PULLED AWAY FROM NEEDLE AND BENT UPON OPENING THE PACKAGE. NO PATIENT CONTACT WITH PRODUCT. MANUFACTURER RESPONSE FOR IV CATHETER KIT, BD INSYTE AUTOGRUARD BC (PER SITE REPORTER): EQUIPMENT FAILURE CALLED TO BECKON DICKINSON COMPANY CUSTOMER SERVICE AT (B)(6). ARRANGEMENTS MADE BY MEDLINE INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612592 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 6357802

    Patients

    Seq Age Sex Outcome Treatment
    1