BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25154225 · Received May 12, 2026

    Report

    Report Number
    1710034-2026-00508
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 28, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    SEE H.11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654. 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

    IT WAS REPORTED THAT THE CATHETER TIP BROKE. INCIDENT DATE: (B)(6) 2026. DETAILS OF COMPLAINT (REPORTED ISSUE): UPON DISCONTINUATION OF THE PATIENTS PERIPHERAL INTRAVENOUS (PIV) LINE AT DISCHARGE ((B)(6) 2026) THE CATHETER TIP FRACTURED AND REMAINED WITHIN THE PATIENT'S BODY. THE EXTERNAL PORTION OF THE PIV SHOWED ONLY A SMALL SEGMENT OF THE CATHETER TIP ATTACHED, INDICATING IT HAD BROKEN OFF. ULTRASOUND IMAGING OF THE PATIENT'S IV SITE WAS PERFORMED TO CONFIRM THAT THE CATHETER TIP REMAINED INSIDE THE VEIN. PERIPHERAL IV WAS INSERTED IN (B)(6) HOSPITAL ON (B)(6) 2026 AT 0410AM. THE PATIENT'S HOSPITAL STAY WAS EXTENDED AS THEY WERE NOT ELIGIBLE FOR DISCHARGE UNTIL NECESSARY IMAGING AND CONSULTATIONS WERE COMPLETED. AN INTERVENTIONAL RADIOLOGY (IR) CONSULT WAS OBTAINED FOR CATHETER REMOVAL; HOWEVER, THE PATIENT WAS NOT A CANDIDATE FOR IR REMOVAL OF THE CATHETER TIP, WHICH REMAINS IN THE PATIENTS ARM. PATIENT HAD SURGERY ON (B)(6) 2026 FOR REMOVAL. TIP IN BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461962 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1