BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25045754 · Received April 30, 2026

    Report

    Report Number
    1710034-2026-00489
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 18, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818334
    PMA / PMN Number
    SEE H.11
    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

    G.4. K201075; K251654. 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

    INVESTIGATION SUMMARY: ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE INFORMATION. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF CATHETER TIP INTEGRITY WITH LOT 5219743 REGARDING ITEM 381433. DEVICE HISTORY REVIEW OF LOT NUMBER 5219743 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY LOT AND PACKAGING LINE. A REVIEW OF THE APPLICABLE RISK DOCUMENT INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER TIP HAD A BULGE. OUR ED STAFF IS HAVING TROUBLE WITH ALL IV CATHETERS WITH THIS LOT #. THEY ARE HAVING TROUBLE ADVANCING THE CATHETER AFTER THE INITIAL PUNCTURE OF THE VEIN, SOME NOT ABLE TO ADVANCE AND BLOWING THE VEIN. AFTER INSPECTION, SEVERAL STAFF BELIEVE THERE IS A SLIGHT BULGE NEAR THE TIP OF THE VIALON CATHETER THAT IS ABNORMAL AND MAY CONTRIBUTE TO THE DIFFICULTY ADVANCING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53888 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5219743 00382903818334

    Patients

    Seq Age Sex Outcome Treatment
    1