BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 22784359 · Received August 12, 2025

    Report

    Report Number
    9610048-2025-00104
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 25, 2025
    Report Date
    September 4, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903818236
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND LOT NUMBER 5031994. 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. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. HOWEVER, THE PROBABLE ROOT CAUSE COULD BE RELATED TO SPRING FORMATION DURING MANUFACTURING. THE OPERATION AND MAINTENANCE CORRECTIONS PERFORMED VARIOUS ADJUSTMENTS AND ALIGNMENTS THAT MAY HAVE BEEN RELATED TO THIS DEFECT. A CORRECTIVE AND PREVENTIVE ACTION PLAN WAS IMPLEMENTED TO PREVENT THE OCCURRENCE OF THIS TYPE OF DEFECT. HOWEVER, THE LOT REPORTED WAS MANUFACTURED PRIOR TO THIS CAPA IMPLEMENTATION. IN ADDITION, THE REPORTED ISSUE OF NEEDLE NOT ACTIVATED MOSTLY LIKELY RESULTED FROM CYLINDER DAMAGE, POSSIBLY CAUSED BY PRESSURE VARIATION OR A FAILURE IN THE SENSOR READING DURING MANUFACTURING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR THE RECORD, WE HAVE FOUND AN ITEM IN OUR STOCK WITH A SUSPECTED QUALITY DEVIATION: INTRAVENOUS CATHETER WITH SAFETY DEVICE 22GA - BD INSYTE AUTOGARD DID NOT TRIGGER THE BUILT-IN SAFETY DEVICE AFTER PUNCTURE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379280 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5031994 30382903818236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown