BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITE~RITE 8 ULTRASOUND SYSTEM 32 MM LINEAR PROBE

    MDR report key: 20782560 · Received November 26, 2024

    Report

    Report Number
    3006260740-2024-07017
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 4, 2024
    Report Date
    January 7, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    IYO
    UDI-DI
    00801741138294
    PMA / PMN Number
    K182281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 DEVICE WAS RETURNED TO THE SERVICE FACILITY FOR EVALUATION. DURING EVALUATION, THE REPORTED ISSUE OF PROBE THAT WAS REPORTED TO HAVE AN IMAGE CLARITY ISSUE WAS UNCONFIRMED. THE UNIT IS GIVING A BRIGHT AND CLEAR IMAGE. THE ROOT CAUSE OF THE REPORTED FAILURE IS INCONCLUSIVE AS THE REPORTED ISSUE COULD NOT BE REPRODUCED DURING EVALUATION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED, WE HAVE A PROBE THAT WAS REPORTED TO HAVE AN IMAGE CLARITY ISSUE. I HAD THE STAFF SWAP IT WITH ANOTHER AND IT LOOKS LIKE THE PROBE IS SHOWING POOR IMAGING REGARDLESS OF THE SITE RITE DEVICE THAT IT IS ATTACHED WITH. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED, WE HAVE A PROBE THAT WAS REPORTED TO HAVE AN IMAGE CLARITY ISSUE. I HAD THE STAFF SWAP IT WITH ANOTHER AND IT LOOKS LIKE THE PROBE IS SHOWING POOR IMAGING REGARDLESS OF THE SITE RITE DEVICE THAT IT IS ATTACHED WITH. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2404925 SITE~RITE 8 ULTRASOUND SYSTEM 32 MM LINEAR PROBE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO C.R. BARD, INC. (BASD) -3006260740 N/A N/A 00801741138294

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other