BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGAURD BC

    MDR report key: 19891447 · Received August 2, 2024

    Report

    Report Number
    1710034-2024-00812
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 2, 2024
    Report Date
    November 4, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382523 AND LOT NUMBER 4030767. 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.

    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 AUTOGAURD BC FOREIGN MATTER ON NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT COMPLAINT. IV CATHETER, COVER WAS REMOVED THERE WAS A DARK BLACK MATERIAL FOUND ON TIP OF THE NEEDLE. 2-3 MM SO PRETTY LARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912449 BD INSYTE AUTOGAURD BC PERIPHERAL IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030767

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown