BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21293049 · Received February 3, 2025

    Report

    Report Number
    1710034-2025-00103
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 13, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. THE PHOTOGRAPH DISPLAYED 3 DISPENSER BOXES CONTAINING 22GA X 1.00IN. INSYTE AUTOGUARD UNITS FROM LOT NUMBER 4102968. THE PHOTO DOES NOT DISPLAY ANY UNITS, JUST THE DISPENSER BOXES. NO DAMAGES CAN BE OBSERVED FROM THE PROVIDED PHOTO THEREFORE WE ARE UNABLE TO CONFIRM YOUR REPORTED ISSUE. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD LEAKAGE AT CATHETER/HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM NUMBER 381823, CUSTOMER ARE HAVING AN ISSUE WITH THESE CANNULAS WHICH APPEARS TO AFFECT THE WHOLE BATCH (THE 3 BOXES CUSTOMER HAVE RECEIVED, SEE BELOW, FROM THE SAME BATCH). ONCE THE CANNULA IS INSERTED AND THE NEEDLE WITHDRAWN, THE AUTOGUARD SYSTEM DOES NOT WORK, AND BLOOD IS LEAKING OUT OF THE CANNULA PRIOR TO CONNECTION OF THE EXTENSION LINE/VALVE. THIS HASN¿T BEEN AN ISSUE WITH PREVIOUS BATCHES OF THESE CANNULA. 22-JAN-2025 1.KINDLY PROVIDE THE EVENT OCCURRENCE DATE. (B)(6) 2025. 2.CAN YOU CONFIRM IS THERE ANY PATIENT IMPACTED? NO IMPACT. 3.CAN YOU CONFIRM THAT THERE ARE ANY SERIOUS INJURIES THAT OCCUR TO THE PATIENT? NO SERIOUS INJURIES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208162 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4102968 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown