BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHERLOCK 3CG+ SENSOR CE

    MDR report key: 17927357 · Received October 12, 2023

    Report

    Report Number
    3006260740-2023-04679
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    October 9, 2023
    Report Date
    October 25, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K180560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    H11: 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: THE SHERLOCK 3CG SENSOR 9770201 WAS VISUALLY INSPECTED, AND NO PHYSICAL DAMAGE WAS FOUND TO THE UNIT. THE REPORTED ISSUE OF INACCURATE ECG READINGS WAS CONFIRMED. THE SENSOR FAILURE DOESN'T CONNECT PRODUCES NO OUTPUT.

    Description of Event or Problem · 0

    IT WAS REPORTED QUESTIONABLE POSITIONING OF PICCS OVER A NUMBER OF WEEKS AND IS CONCERNED THAT THE SHERLOCK PADDLE IS NOT WORKING CORRECTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED QUESTIONABLE POSITIONING OF PICCS OVER A NUMBER OF WEEKS AND IS CONCERNED THAT THE SHERLOCK PADDLE IS NOT WORKING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133253 SHERLOCK 3CG+ SENSOR CE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other