BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE

    MDR report key: 23075176 · Received September 17, 2025

    Report

    Report Number
    9610048-2025-00122
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 15, 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

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 38831114 AND LOT NUMBER 4183704. 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 SAMPLES WERE UNAVAILABLE FOR THIS EVENT, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. ALTHOUGH AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS COMPLAINT IT IS POSSIBLE THAT THE REPORTED DEFECT RESULTED FROM PRODUCT USE. DURING THE 360-DEGREE ROTATION PERFORMED DURING PUNCTURE, THE CATHETER MAY HAVE BEEN PUSHED FORWARD, RE-CANNULATING THE DEVICE AND CAUSING THE CATHETER TO BECOME TRANSFIXED. IT IS ALSO POSSIBLE THAT DURING PRODUCT ASSEMBLY, A FAILURE IN THE VISION SYSTEM ALLOWED A TRANSFIXED CATHETER TO PASS THROUGH TO THE CUSTOMER. HOWEVER, IF THE CATHETER WAS TRANSFIXED PRIOR TO PUNCTURE, USE OF THE PRODUCT WOULD NOT BE POSSIBLE. IMPROVEMENT ACTIONS OF THE ISSUE OF NEEDLE THROUGH CATHETER WERE IMPLEMENTED THROUGH A PREVIOUS CORRECTIVE AND PREVENTIVE ACTION PLAN FROM SEPTEMBER 2024. THE LOT INVOLVED IN THIS REPORT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THESE ACTIONS. 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 THE ABOCATH TIP BECAME BLUNT AND THE PLASTIC RUPTURED, NOT ALLOWING IT TO ADVANCE INTO THE VEIN, USING A GREATER AMOUNT OF ABOCATH AND PUNCTURING THE PATIENT'S SKIN MORE SEVERELY. DAMAGE TO VEINS AND SKIN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531248 INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4183704 00382903883110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown