BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 22913712 · Received August 28, 2025

    Report

    Report Number
    9610048-2025-00113
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    July 22, 2025
    Report Date
    October 13, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND LOT NUMBER 5083552. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, BASED ON THE PREVIOUS INVESTIGATION RESULTS THE PROBABLE CAUSES MIGHT BE, THE FAILURE DURING TRANSPORTATION AND/OR DURING PRODUCT HANDLING OR A DETECTION FAILURE DURING THE PRODUCT OPERATION PROCESS ON THE PRODUCT PACKAGING CONVEYOR OR IN THE AUTOMATIC FEEDER. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THEM. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    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

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE OF THE CATHETER DISCONNECTS EASILY FROM THE EXTENDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520561 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5083552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown