BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 22302261 · Received June 20, 2025

    Report

    Report Number
    9610048-2025-00082
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    June 3, 2025
    Report Date
    November 21, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    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

    CORRECTION EVENT DATE IS NOT KNOWN. UPDATED IN B BY REFLECTING THE AWARE DATE OF THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38181214 AND LOT NUMBER 4122892. 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 EVENTS. FOR REPORTED ISSUE WITH SAFETY DEVICE, 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. 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: INSYTE AUTO GUARD HAS BEEN REPORTED TO HAVE: DIFFICULTIES WITH THE SAFETY DEVICE.

    Description of Event or Problem · 0

    THEY WERE UNABLE TO MENTION THE NUMBER OF TIMES OR EVEN THE DATE.

    Description of Event or Problem · 0

    16-JUNE: THEY WERE UNABLE TO MENTION THE NUMBER OF TIMES OR EVEN THE DATE, BUT THEY REPORTED THAT THEY HAD SEVERAL EPISODES, MANY OF WHICH HAD LED TO HEMATOMA IN THE CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780882 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4122892 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown