BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23162411 · Received September 27, 2025

    Report

    Report Number
    9610048-2025-00132
    Event Type
    Malfunction
    Date Received
    September 27, 2025
    Date of Event
    August 21, 2025
    Report Date
    October 6, 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 5091283. 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. 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. HOWEVER, FOR A DETAILED ANALYSIS, THE PRESENCE OF THE PHYSICAL SAMPLE WOULD BE NECESSARY. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER VENIPUNCTURE WITH A JELCO 22 BD INSYTE AUTOGUARD NEEDLE, DID NOT RETRACT THE NEEDLE INTO THE SAFETY COVER. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON SEPTEMBER 19, 2025 WAS THERE ANY DAMAGE TO THE PATIENT'S HEALTH? IF SO, PLEASE EXPLAIN IN DETAIL. THERE WAS NO DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525141 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5091283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown