BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC

    MDR report key: 20613793 · Received November 5, 2024

    Report

    Report Number
    1710034-2024-01269
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 3, 2024
    Report Date
    January 28, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 190 SEALED 22GA X 1.00IN. INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 4190487. A FUNCTIONAL TEST THAT SIMULATES INSERTION AND MEASURES THE CATHETER TIP AND NEEDLE TIP PENETRATION FORCES SHOWED THAT THE UNITS WERE WITHIN SPECIFICATION. NO RESISTANCE OR KINKING WAS OBSERVED DURING INSPECTION. YOUR REPORT OF A KINK IN THE IV CATHETER COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 22GA INSYTE AUTOGUARD BC UNITS THAT WERE RECEIVED. 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.

    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 AUTOG BC CATHETER KINKS DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER ADVISED THAT THE 22G INSYTE IV CATHETERS ARE KINKING UP INSIDE THE PATIENTS VEINS AND ARE CAUSING THE PRESSURE ON THE INJECTOR TO GO UP A LOT. THE CATHETERS ARE TOTALLY BENT WHEN TAKEN OUT OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992065 BD INSYTE AUTOGUARD BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4190487 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown