BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N AUTOGUARD

    MDR report key: 24140296 · Received January 21, 2026

    Report

    Report Number
    1710034-2026-00033
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 17, 2026
    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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381511 AND LOT NUMBER 5210670. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT SIMILAR ISSUES DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 381511. BATCH # 5210670. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. AFTER USING A WINGED CATHETER, IT WOULD NOT COLLAPSE; THE SAFETY MECHANISM FAILED. LOT#: 5210670.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200052 BD INSYTE-N AUTOGUARD CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5210670 00382903815111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown