BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23799443 · Received December 14, 2025

    Report

    Report Number
    9610048-2025-00183
    Event Type
    Malfunction
    Date Received
    December 14, 2025
    Date of Event
    October 18, 2025
    Report Date
    December 30, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818334
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: (E) INITIAL REPORTER DETAILS. INVESTIGATION RESULTS: IN ADDITION TO THE FACT THAT NO RECORDS WERE FOUND DURING THE ANALYSIS OF THE BATCH HISTORY AND NON-COMPLIANCE RECORDS, THERE IS NO EVIDENCE THAT COULD LEAD TO THIS COMPLAINT, WE DID NOT RECEIVE SAMPLES/PHOTOS TO ANALYZE THIS COMPLAINT, AND IT IS NOT POSSIBLE TO CONFIRM THIS COMPLAINT. BASED ON THE RESULTS OF THE INVESTIGATION, TO DATE A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS COMPLAINT. A PROBABLE ROOT CAUSE MAY ALSO BE RELATED TO DAMAGE TO THE CYLINDER, CAUSED BY A POSSIBLE PRESSURE VARIATION OR A FAILURE IN THE SENSOR READING AT STATION 5.52.4 (BARREL POSITIONING STATION). THIS DAMAGE MAY LEAD TO INCOMPLETE NEEDLE ACTIVATION AND/OR MAY BE ASSOCIATED WITH A FAILURE IN THE UV ADHESIVE APPLICATION PROCESS, RESULTING IN THE ADHESIVE BEING APPLIED ON THE BUTTON INSTEAD OF ON THE COMPONENT HUB. HOWEVER, FOR A DETAILED ANALYSIS, THE PRESENCE OF THE PHYSICAL SAMPLE WOULD BE NECESSARY. THE DEFECTS WILL BE MONITORED DURING QUALITY TREND ANALYSIS (QDA) MEETINGS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ALL DEMOGRAPHIC INFORMATION ON THE REGULATORY DOCUMENT STATES "CONFIDENTIAL".

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 20G VENOUS CATHETER MALFUNCTIONED, OPENING IN THE PATIENT'S VEIN AND FAILING TO ACTIVATE THE SAFETY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186370 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5066394 00382903818334

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown