BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24955887 · Received April 22, 2026

    Report

    Report Number
    1710034-2026-00452
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H. ATTACHED MEDWATCH INVESTIGATION SUMMARY: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE SHIELDING FAILURE WITH LOT 6020809 REGARDING ITEM #382533. DEVICE HISTORY RECORD FOR FINAL LOT NUMBER 6020809 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND FOR THE SUBASSEMBLY OR FINAL LOT NUMBERS. 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

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. "BD INSYTE AUTOGUARD BC IV NEEDLE DID NOT RETRACT UPON INSERTION. NEEDLE WAS CAREFULLY REMOVED AND WHEN NEEDLE WAS COMPLETELY FREE, RETRACTED BY ITSELF. IT DID NOT AFFECT PLASTIC CATHETER, BLOW VEIN, INJURE PATIENT. ALTHOUGH THERE WAS NO HARM NOTED TO THE PATIENT, THE NEEDLE HAD TO BE MANUALLY RETRACTED AND THUS THERE WAS A RISK FOR INJURY TO THE USER/NURSE INSERTING THE IV. WE HAVE IDENTIFIED A TREND WITH THIS ISSUE/LOT NUMBER LOT 6020809".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352288 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6020809 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male