BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD

    MDR report key: 23621697 · Received November 21, 2025

    Report

    Report Number
    1710034-2025-01852
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 26, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815111
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF A DAMAGED CATHETER TIP WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. TWO 24G INSYTE-N AUTOGUARD UNITS WERE PROVIDED FOR INVESTIGATION FROM LOTS 3114869 AND 5051385. THE SAMPLES EXHIBITED EVIDENCE OF USE. THE NEEDLES WERE RECEIVED FULLY RETRACTED WITHIN THE SAFETY SHIELD. THE IV CATHETERS WERE RECEIVED SEPARATE FROM THE NEEDLES AND UNIT PACKAGES. BECAUSE THEY WERE RECEIVED SEPARATE FROM THE PACKAGES, IT IS UNCLEAR WHICH UNIT BELONGS TO WHICH LOT. A FUNCTIONAL TEST REVEALED A LEAK IN ONE OF THE IV CATHETERS. A MICROSCOPIC ANALYSIS OF THE LEAK SITE REVEALED A V-SHAPE BREACH IN THE CATHETER TUBING NEAR THE TIP, WHICH WAS CONSISTENT FOR NEEDLE PUNCTURE DAMAGE. NO DAMAGE WAS IDENTIFIED ON THE OTHER IV CATHETER. DUE TO THE EVIDENCE OF USE, THE DAMAGE MAY HAVE OCCURRED DURING THE INSERTION PROCESS. THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT IF THE NEEDLE IS PARTIALLY OR COMPLETELY WITHDRAWN FROM THE CATHETER TUBING DURING INSERTION, DO NOT RE-INSERT THE NEEDLE INTO THE CATHETER TUBING AS DAMAGE MAY OCCUR. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    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.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    RN ATTEMPT X2 TO PLACE PIV USING 24GAUGE 0.56IN CATHETER BD INSYTE-N AUTOGUARD LOT 3114869 EXP 3/31/2026 AND LOT 2021385 EXP 1/31/2028. BOTH TIMES THE CATHETER TIP WAS SPLIT AND FRAYED. RESULTING IN 3 IV STICKS FOR THIS INFANT. SWITCHED TO 26GAUGE CATHETER WITHOUT INCIDENT. I SPOKE WITH SAM AND HE THOUGHT THEY WERE FRAYED BEFORE INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089254 INSYTE-N AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3114869 00382903815111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown