BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20669285 · Received November 12, 2024

    Report

    Report Number
    1710034-2024-01328
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 25, 2024
    Report Date
    February 3, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    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. CUSTOMER ALSO PROVIDE LOT NUMBER 4190991 WHICH DOES NOT PULL A VALID MATERIAL NUMBER FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TWO SEALED 20GA X 1.16IN. INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 4260454. A VISUAL INSPECTION DID NOT DISCOVER ANY DEFECTS TO THE RETURNED UNITS THAT RESEMBLED OR DISPLAYED THE NEEDLE PIERCING THROUGH THE CATHETER WALL. 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 NSYTE AUTOG BC NEEDLE PIERCING THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV CATHETER IS SHEERING THROUGH NEEDLE. 29OCT: THE SELF-OCCLUDING IV CATHETERS ARE SHEERING THE INSIDE OF THE PLASTIC CATHETER. THIS WAS NOTICED DURING USE. NO PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058892 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4260454 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown