BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21608040 · Received March 14, 2025

    Report

    Report Number
    1710034-2025-00402
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 12, 2025
    Report Date
    April 1, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814121
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 67 SEALED 24GA X 0.75IN. INSYTE AUTOGUARD UNITS FROM LOT NUMBER 4123600. A SAMPLING OF 20 UNITS WERE RANDOMLY SELECTED FOR FUNCTIONAL TESTING. THE 20 UNITS WERE INSPECTED BY BREAKING TIP ADHESION, SLIGHTLY ADVANCING THE CATHETER, AND ACTIVATING THE BUTTON. EACH UNIT RETRACTED SUCCESSFULLY AND WITHIN SPECIFICATIONS. A VISUAL INSPECTION DID NOT DISCOVER ANY DAMAGES THAT MAY INDICATE NEEDLE RETRACTION DIFFICULTIES. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    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: DURING INFUSION THE CATHETER LOCKED UP AND THE RN WAS NO ABLE TO UTILIZE THE DEVICE. PT HARM: NO. CUSTOMER RESPONSE ON (B)(6)2025. THE DATE OF THE EVENT WAS 02/12/2025. CUSTOMER RESPONSE ON (B)(6)2025. YES, THE NEEDLE FAILED TO RETRACT. NO, IT WAS NOT OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547686 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4123600 00382903814121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown