BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23441799 · Received October 31, 2025

    Report

    Report Number
    9610048-2025-00159
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    August 18, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883110
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURES DID NOT ALLOW FOR VISUALIZATION OF THE REPORTED DAMAGE TO THE ADAPTER. FOR A PROPER ANALYSIS, A PICTURE CLEARLY SHOWING THE ADAPTER COMPONENT AND ANY REPORTED DAMAGE WOULD BE REQUIRED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 4183704. THE REVIEW FOUND MAINTENANCE RECORDS FOR THE LOT INVOLVED. THE MAINTENANCE RECORDS MAY BE RELATED TO THE REPORTED INCIDENT AS THEY WERE ASSOCIATED WITH ¿ADAPTER DAMAGE.¿ ALTHOUGH THE PICTURES DID NOT SHOW THE DEFECT CLEARLY, IT HAS BEEN CONCLUDED THAT THIS INCIDENT WAS RELATED TO THE MAINTENANCE HISTORY ON THE TIPPER MACHINES. MISALIGNMENT OF THE TIPPER MACHINE INDEX CAN CAUSE DAMAGE TO THE ADAPTER, WHICH MAY LEAD TO DIFFICULTIES IN CONNECTION. THIS WOULD BE A PROBABLE CAUSE. A PREVIOUS CORRECTIVE AND PREVENTIVE ACTION PLAN WAS IMPLEMENTED IN (B)(6) 2025 FOR THIS ISSUE. THE PLAN COVERED VARIOUS STEPS ON MINIMIZING THE RISK OF ADAPTER DAMAGE, INCLUDING AN ALERT IF A LOSS OF SYNCHRONISM BETWEEN THE INDEXER/INDEX OCCURS AND A DESCRIPTION ON HOW TO RESTORE IT, A VERIFICATION FOR SYNCHRONISM, GUIDANCE FOR HOW TO PROCEED IF ADAPTER DAMAGE IS IDENTIFIED, AND TRAINING ON THE CHANGES. HOWEVER, THE LOT INVOLVED IN THIS INCIDENT WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTIONS. AT THIS TIME, ADDITIONAL ACTIONS HAVE NOT BEEN DETERMINED NECESSARY. THIS IS THE FIRST REPORT RECEIVED FOR THIS TYPE OF ISSUE ON MATERIAL NUMBER 38831114 AND LOT NUMBER 4183704. 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

    H3: 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

    AN INTRAVENOUS LINE IS INSERTED INTO THE LEFT HAND. AFTER CHECKING FOR BLOOD RETURN, THE INTRAFIX IS CONNECTED, BUT DIFFICULTY IS ENCOUNTERED IN CONNECTING IT CORRECTLY. WHEN THE INTRAFIX VALVE FOR MEDICATIONS IS OPENED, THE MEDICATION LEAKS OUT THREE TIMES FROM THE CONNECTION BETWEEN THE CATHETER AND THE INTRAFIX. THE SAME THING HAPPENS WITH THE HELP OF ANOTHER COLLEAGUE, AND FINALLY THE CATHETER IS REMOVED, CAUSING DISCOMFORT TO THE PATIENT. ACCORDING TO THE CLINIC, THE SERIOUSNESS OF THE INCIDENT IS MODERATE AND THE CONSEQUENCE WAS A TEMPORARY INJURY. THE CASE WAS REPORTED BY THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906748 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4183704 00382903883110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown