BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 22309315 · Received June 23, 2025

    Report

    Report Number
    9610048-2025-00083
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 4, 2025
    Report Date
    July 31, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    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

    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 5002443. 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: IT WAS REPORTED THAT INSYTE AUTOGARD HAD A PROBLEM WITH THE SAFETY DEVICE, IT WAS NOT RETRACTING THE NEEDLE, IT WAS OPENING INSIDE THE PATIENT'S ARM, DURING COLLECTION IN THE ADULT EMERGENCY ROOM. ADDITIONAL INFORMATION RECEIVED ON JUNE 6, 2025. COULD YOU CLARIFY WHEN THE EVENT WAS FIRST REPORTED BY THE CUSTOMER TO BD? - IT WAS REPORTED ON JUNE 4 AT 7:30 P.M., BUT THEY WERE UNABLE TO PROVIDE THE DATE OF THE INCIDENT. ADDITIONAL INFORMATION RECEIVED ON JUNE 16, 2025. NURSING STAFF REPORTED THAT THE INSYTE AUTO GUARD WAS NOT RETRACTING THE NEEDLE WHEN THE SAFETY DEVICE WAS ACTIVATED. EVEN WHEN THE DEVICE WAS ACTIVATED, THE NEEDLE REMAINED IN THE PATIENT'S ARM, CAUSING DISCOMFORT AND BRUISING. IN SOME CASES, THE ACCESS WAS LOST AND A NEW PUNCTURE HAD TO BE MADE. THEY WERE UNABLE TO SAY WHEN THIS HAPPENED BUT SAID THAT THEY HAD WITNESSED IT FOUR TIMES IN ONE DAY WITH DIFFERENT PATIENTS AND COLLABORATORS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926833 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5002443 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown