BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 18738160 · Received February 20, 2024

    Report

    Report Number
    18738160
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 8, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IV CATHETER TIP DULL. HEALTHCARE PROVIDER HAD TO RE-STICK PATIENT, DUE TO NOT BEING ABLE TO POKE THRU THE SKIN. THIS ISSUE HAS BEEN CAUSING ADDITIONAL STICKS AND UNNECESSARY PAIN FOR THE PATIENT. CATHETER WAS DISCARDED. LOT# 3251082 EXP: 08-31-2026 20G AUTOGUARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085361 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 382533 3251082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown