BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITE~RITE 8 ULTRASOUND SYSTEM, US

    MDR report key: 7809213 · Received August 23, 2018

    Report

    Report Number
    3006260740-2018-02194
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Report Date
    August 30, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    IYO
    UDI-DI
    00801741138263
    PMA / PMN Number
    K152554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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: THE DEVICE WAS RETURNED TO THE SERVICE FACILITY FOR EVALUATION. DURING EVALUATION, THE REPORTED ISSUE OF POOR IMAGE QUALITY WAS UNCONFIRMED. DURING INSPECTION THE SCANNER WAS EVALUATED WITH THE MODEL 550 PHANTOM, THE IMAGE WAS FOUND TO BE NORMAL FOR THE SR 8 SCANNER. THE ROOT CAUSE OF THE REPORTED FAILURE IS INCONCLUSIVE AS THE REPORTED ISSUE COULD NOT BE REPRODUCED DURING EVALUATION. NO OTHER FUNCTIONALITY ISSUES WITH THE EQUIPMENT WERE FOUND DURING EVALUATION/SERVICING. THE DEVICE WAS SERVICED, TESTED AND RETURNED TO THE CUSTOMER. A HISTORY REVIEW OF SERIAL NUMBER (B)(4) SHOWED NO OTHER SIMILAR COMPLAINT(S) FROM THIS SERIAL NUMBER.

    Description of Event or Problem · 0

    THE BD CLINICAL SPECIALIST REPORTED ON BEHALF OF THE VASCULAR ACCESS TEAM DIRECTOR THAT THE SR 8 ULTRASOUND (9770600) HAS POOR IMAGE QUALITY , STATING THE QUALITY IS GRAINY AND DARK. THIS IS CAUSING THE END USERS TO NOT VISUALIZE THE NEEDLE. THIS IMPACTS PATIENTS DUE TO MULTIPLE NEW VESSEL ACCESS AND DELAYED PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A HISTORY REVIEW OF SERIAL NUMBER (B)(4) SHOWED NO OTHER SIMILAR COMPLAINT(S) FROM THIS SERIAL NUMBER.

    Description of Event or Problem · 1

    THE BD CLINICAL SPECIALIST REPORTED ON BEHALF OF THE VASCULAR ACCESS TEAM DIRECTOR THAT THE SR 8 ULTRASOUND (9770600) HAS POOR IMAGE QUALITY , STATING THE QUALITY IS GRAINY AND DARK. THIS IS CAUSING THE END USERS TO NOT VISUALIZE THE NEEDLE. THIS IMPACTS PATIENTS DUE TO MULTIPLE NEW VESSEL ACCESS AND DELAYED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652357 SITE~RITE 8 ULTRASOUND SYSTEM, US SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BARD ACCESS SYSTEMS 9770600 00801741138263

    Patients

    Seq Age Sex Outcome Treatment
    1