BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24767370 · Received April 2, 2026

    Report

    Report Number
    1710034-2026-00366
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 17, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826230
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, (B)(6) WAS USED AS THE STATE. 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.

    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 SAFETY SHIELD ACTIVATION FAILURE (CATHETER) WITH LOT 5339236 REGARDING ITEM 382623. DHR NUMBER 5339236 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 DOCUMENTS INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED AND ADDED TO B.1. DESCRIBE EVENT OR PROBLEM

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE SLIPPED RETRACTION AFTER RETRACTION. "RN PUSHED WHITE BUTTON TO RETRACT THE NEEDLE AFTER IV WAS PLACED. RN PLACED THE RETRACTED NEEDLE PIECE ON PATIENT'S BED AFTER IV PLACEMENT. WHEN PLACING NEEDLE PIECE ON BED, NEEDLE EJECTED. NEITHER STAFF NOR PATIENT WAS HARMED.".

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: 9-APR-2026: DID THE NEEDLE INITIALLY COMPLETELY RETRACT? AND THEN CAME OUT OF THE HOUSING AGAIN WHEN IT WAS SET DOWN? GOOD MORNING, YES, THAT IT CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249880 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5339236 00382903826230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown