BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD

    MDR report key: 24715998 · Received March 30, 2026

    Report

    Report Number
    1710034-2026-00339
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 1, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814114
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO B TAB. ANNEX E AND F CODES UPDATED.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. YOUR REPORT OF A DAMAGED CATHETER COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 24G INSYTE AUTOGUARD DEVICES THAT WERE PROVIDED FOR INVESTIGATION. THIRTY FIVE UNITS FROM THE IMPLICATED LOT WERE RECEIVED AND SUBJECTED TO GROSS VISUAL INSPECTION, WHICH FOUND ALL UNITS SEALED IN ORIGINAL PACKAGING WITH NO VISIBLE PHYSICAL DAMAGE. A FUNCTIONAL TEST TO SIMULATE THE NEEDLE TIP PENETRATION, CATHETER TIP PENETRATION, AND CATHETER DRAG REVEALED THAT THE MEASURED FORCES WERE WITHIN SPECIFICATION. ALL EVALUATED UNITS MET APPLICABLE SPECIFICATIONS, AND NO DAMAGE OR ANOMALIES ASSOCIATED WITH THE REPORTED CONDITION WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER IS SHEARING. CATHETERS SHEARING. ADDITIONAL INFORMATION 6 MAR 2026: THE CATHETERS APPEARED INTACT BEFORE POKING. ONCE THE CATHETER PUNCTURED THE SKIN, THE PLASTIC IMMEDIATELY SHEERED AND YOU WERE NOT ABLE TO ADVANCE. TOTAL NUMBER OF OCCURRENCES? I KNOW OF AT LEAST 4 INCIDENCES IN NIC 1 OVER 24 HOURS. I HAVE HEARD THAT OTHERS ALSO HAD ISSUSE BUT HADN'T REPORTED THEM. IN ADDITION TO THE 4 NICU IN 24 HOURS, PRIOR TO THAT THERE HAD BEEN A HANDFUL OF INCIDENCES STARTING THE WEEKEND BEFORE (2/21-2/22). THESE WERE DISCOVERED AFTER ASKING FREQUENT INSERTERS IF THEY HAVE HAD ISSUES. ALL OF THE INSERTERS HAD THE SAME REACTION SAYING "YES! I THOUGHT IT WAS JUST ME." OTHER INSTANCES I HAVE DOCUMENTED ARE 2 SHEERING 2/23, AND AT LEAST 2 ON 2/27 FROM OUR PEDIATRIC ED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: 30-MAR-2026: THERE WAS NOT HARM TO THE PATIENTS OTHER THAN REQUIRING AN ADDITIONAL POKE TO OBTAIN PERIPHERAL ACCESS.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776609 INSYTE-N AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5287386 00382903814114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown