BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 22472736 · Received July 10, 2025

    Report

    Report Number
    9610048-2025-00091
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    February 25, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND LOT NUMBER 4242802. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE NEEDLE SAFETY FEATURE OF THE PRODUCT WAS OBSERVED PARTIALLY ACTIVATED. VISIBLE DAMAGE WAS OBSERVED TO THE CYLINDER COMPONENT, WHICH WAS THE CAUSE OF THE INCOMPLETE RETRACTION. THE DAMAGE TO THE CYLINDER WAS LIKELY CAUSED BY A PRESSURE VARIATION OR A SENSOR FAILURE READING IN THE BARREL POSITIONING STATION. THE DAMAGE MAY HAVE THEN CAUSED THE REPORTED ISSUE, PREVENTING THE FULL ACTIVATION OF THE NEEDLE RETRACTION FEATURE. THIS IS THE FIRST REPORT RECEIVED FOR THIS TYPE OF ISSUE ON MATERIAL 38182314 AND LOT 4242802. 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: NSYTE AUTOGUARD 22GA X 1.00 (0,9X 25MM) SAFETY DEVICE PRESENTED FAILURE. ADDITIONAL INFORMATION RECEIVED ON 26JUN2025 WHAT WAS THE MALFUNCTION ASSOCIATED WITH THE DEVICE? SAFETY DEVICE FAILED TO ACTUATE ON FIRING. IS THERE ANY IMPACT ON PATIENTS? IF SO, PLEASE EXPLAIN IN DETAIL? PRODUCT DOES NOT MEET SAFETY FUNCTION (HEALTH PROFESSIONAL PROTECTION).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 22JUL2025: WAS THERE ANY HARM OR SERIOUS INJURY TO PATIENT OR HEALTHCARE WORKER DIRECTLY RELATED TO THIS REPORTED EVENT? THERE WAS NO INJURY RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046282 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4242802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown