BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17595559 · Received August 22, 2023

    Report

    Report Number
    1710034-2023-00936
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 1, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 22GA X 1.00IN. INSYTE AUTOGUARD BC PRO UNIT FROM LOT NUMBER 2336531. ADDITIONALLY, 7 PHOTOS WERE RECEIVED WHICH ARE REPRESENTATIVE OF WHAT WAS RETURNED. THE FOREIGN MATTER WAS PROVIDED ON A GLASS CONTAINER WHEN RECEIVED AND THE NEEDLE WAS RETRACTED. MICROSCOPIC ANALYSIS DISCOVERED WHAT APPEARS TO BE A CLEAR GEL-LIKE MATTER. THE REPORTED ISSUE WAS CONFIRMED. AS THE FOREIGN MATTER AS OBSERVED IN THE FLUID PATH, FURTHER SPECTRAL ANALYSIS WILL BE PERFORMED. AS THE DEVICE WAS RECEIVED RETRACTED AND IN AN UNSEALED PACKAGE, IT CANNOT BE DETERMINED IF THE FOREIGN MATTER PRESENTED DURING MANUFACTURING OR WAS INTRODUCED IN THE CLINICIAN ENVIRONMENT. OUR SPECTRAL ANALYSIS MACHINE IS CURRENTLY UNDER REPAIR. ONCE OUR MACHINE IS REPAIRED, WE WILL CONTINUE OUR INVESTIGATION AND RESPOND WITH THE RESULTS.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD FOREIGN MATTER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THIS REPORT IS ABOUT FM. A BLACK DOT WAS INSIDE THE TIP OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPOTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD FOREIGN MATTER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THIS REPORT IS ABOUT FM. A BLACK DOT WAS INSIDE THE TIP OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311347 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2336531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown