BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITE~RITE 8 ULTRASOUND SYSTEM

    MDR report key: 19634959 · Received June 28, 2024

    Report

    Report Number
    3006260740-2024-03322
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 10, 2024
    Report Date
    September 13, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    IYO
    PMA / PMN Number
    K152554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DEVICE WAS RETURNED TO SERVICE FACILITY FOR EVALUATION. DURING EVALUATION, THE REPORTED ISSUE OF THE PROBE HAS POOR CLARITY ON THE IMAGES WAS CONFIRMED. THE PROBE WAS FOUND DAMAGED. THE ROOT CAUSE IS LIKELY DUE TO USE-RELATED DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROBE DOESN'T WORK AND THERE IS A POOR CLARITY OF THE ULTRASOUND IMAGE. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROBE DOESN'T WORK AND THERE IS A POOR CLARITY OF THE ULTRASOUND IMAGE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787027 SITE~RITE 8 ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO C.R. BARD, INC. (BASD) -3006260740 N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other