BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHERLOCK (ADVANTECH)

    MDR report key: 22378346 · Received July 1, 2025

    Report

    Report Number
    3006260740-2025-04466
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 17, 2025
    Report Date
    August 28, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K180560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 IT 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 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 THE ¿LOLLIPOP¿ TRACKS FROM THE SHOULDER ACROSS THE SUBCLAVIAN AND WILL OFTEN TRACK UP IF THE PICC GOES UP THE JUGULAR BUT IS NOT RELIABLE TRACKING DOWN TOWARDS THE SCV. IT STOPS AT THE SUBCLAVIAN REGION AND DOES NOT PROGRESS. THE ECG IS THEN THE ONLY SIGN THAT IT IS PROGRESSING IN THE CORRECT DIRECTION WAS CONFIRMED. THE LOLLIPOP INDICATOR FOR THE SENSOR DOES NOT MOVE BELOW THE CENTER OF THE DISPLAY. THE INDICATOR WILL TRACK UPWARD BUT IS NOT RELIABLE TO TRACK DOWNWARD. THE ROOT CAUSE OF THE REPORTED FAILURE WAS IDENTIFIED AS AN INTERNAL FAILURE OF THE USB CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE ¿LOLLIPOP¿ TRACKS FROM THE SHOULDER ACROSS THE SUBCLAVIAN AND WILL OFTEN TRACK UP IF THE PICC GOES UP THE JUGULAR BUT IS NOT RELIABLE TRACKING DOWN TOWARDS THE SCV. IT STOPS AT THE SUBCLAVIAN REGION AND DOES NOT PROGRESS. THE ECG IS THEN THE ONLY SIGN THAT IT IS PROGRESSING IN THE CORRECT DIRECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381502 SHERLOCK (ADVANTECH) SHERLOCK (ADVANTECH) LJS C.R. BARD, INC. (BASD) -3006260740 N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other