BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21437042 · Received February 21, 2025

    Report

    Report Number
    1710034-2025-00297
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 30, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. HOWEVER, THE REPORTED DEFECT OF NEEDLE RETRACTION FAILURE IS CONFIRMED SINCE A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE MODE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTIFY THE ROOT CAUSE. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA#.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DISCOVERED DURING PATIENT CARE: YES. NATURE OF PATIENT CARE: THE NEEDLE FOR THE 22 GAGE ANGIO CATHETER WAS NOT RETRACTING, THE STAFF WAS ABLE TO MITIGATE ANY PATIENT INJURIES THROUGH CAREFUL MANUAL RETRACTION TO PREVENT FURTHER INJURY. DATE OF EVENT: 1/30/2025 12:00:00 AM. WAS PATIENT OR END-USER INJURED: NO. INJURY DETAILS: WAS MEDICAL TREATMENT REQUIRED: NO. TREATMENT DETAILS: PATIENT CURRENT STATUS: FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619680 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4229661 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown