BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20185538 · Received September 10, 2024

    Report

    Report Number
    1710034-2024-01006
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    July 25, 2024
    Report Date
    October 17, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    *NOTE THIS PRODUCT DOES NOT HAVE A BLOOD CONTROL FEATURE. 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: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381423 AND LOT NUMBER 3192238. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. BASED ON THE INFORMATION PROVIDED WE DID PERFORM A DHR ON THE LOT PROVIDED WHICH CORRESPONDS TO MATERIAL 381423. THE PROVIDED INFORMATION DOES NOT INDICATE THAT THIS IS A BLOOD CONTROL DEVICE, IT IS RECOMMENDED THAT PRIOR TO THE USE OF BD PRODUCTS TO REVIEW THE INSTRUCTIONS FOR USE DOCUMENTATION SUPPLIED TO ENSURE THE GREATEST CHANCES OF THERE BEING NO FAILURES DURING PRODUCT APPLICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD BLOOD BACK FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD INSYTE AUTO GUARD 22 GA. CATHETER AUTO GUARD MALFUNCTIONED. BLOOD FLOWED FROM CATHETER AND WAS NOT STOPPED BY AUTO GUARD. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336667 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192238 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown