BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED)

    MDR report key: 15764727 · Received November 9, 2022

    Report

    Report Number
    3006260740-2022-04864
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    November 4, 2022
    Report Date
    December 10, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    IYO
    UDI-DI
    00801741138201
    PMA / PMN Number
    K182281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. A HISTORY REVIEW OF SERIAL NUMBER (B)(4) SHOWED ONE SIMILAR COMPLAINT FROM THIS SERIAL NUMBER. THE SIMILAR COMPLAINTS HAVE BEEN REPORTED BY THE SAME US FACILITY. THE PREVIOUS COMPLAINT EVALUATION FOR THIS SERIAL NUMBER (B)(4) IS: INCONCLUSIVE, NO SAMPLE RETURNED FOR EVALUATION. (REFERENCE: MDR NUMBER 3006260740-2020-21407).

    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 FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: OBSERVATION FOUND DURING EVALUATION OF ORIGINAL FILE 6061131: THE IMAGE IS VERY POOR, IT DISPLAYS THREE BLACK VERTICAL LINES RUNNING DOWN THE IMAGE. THE ROOT CAUSE OF THE FAILURE WAS IDENTIFIED AS A PROBE FAILURE. H3 OTHER TEXT: EVALUATION FINDINGS ARE IN SECTION H11.

    Description of Event or Problem · 0

    THE IMAGE IS VERY POOR, IT DISPLAYS THREE BLACK VERTICAL LINES RUNNING DOWN THE IMAGE.

    Description of Event or Problem · 0

    THE IMAGE IS VERY POOR, IT DISPLAYS THREE BLACK VERTICAL LINES RUNNING DOWN THE IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2952912 SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED) SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO C.R. BARD, INC. (BASD) -3006260740 9770602Y 00801741138201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other