BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N AUTOGUARD

    MDR report key: 20245526 · Received September 18, 2024

    Report

    Report Number
    20245526
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 6, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE 20 GAUGE WAS BENT WHEN THE RN TRIED TO INSERT IT WHICH CAUSED THE IV TO NOT WORK PROPERLY AND THE PT HAD TO HAVE A NEW IV PLACED. LOT# 4102957.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319623 BD INSYTE-N AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 4102957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other