BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHERLOCK 3CG PLUS TCS

    MDR report key: 16501690 · Received March 8, 2023

    Report

    Report Number
    3006260740-2023-00718
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 9, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741163029
    PMA / PMN Number
    K180560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. A HISTORY REVIEW OF SERIAL NUMBER (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS SERIAL NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE P-WAVE TECHNOLOGY WAS NOT CONSISTENTLY CAPTURING THEIR PEAKED P-WAVES ACCURATELY, CAUSING THEM TO LEAVE TOO MUCH EXTERNAL LENGTH OR ADVANCING TOO FAR IN WITH CATHETER ON THE SMALL TABLET. SAID TECHNOLOGY WAS INCONSISTENT CONFIRMING PLACEMENT, AS SOMETIMES IT WOULD WORK PROPERLY. BUT DUE TO THEIR LACK OF CONFIDENCE IN THE TECHNOLOGY, THEY STILL ORDERED CXR TO CONFIRM TIP PLACEMENT. IT WAS REPORTED BY BD CLINICAL SPECIALIST ¿I WENT TO THE ACCOUNT TODAY TO OBSERVE THEIR SET UP AND PICC INSERTION ON PEDIATRIC PATIENT USING THE SMALL SHERLOCK 3CG TECHNOLOGY. THE TECHNOLOGY DID IN FACT FAIL TO FUNCTION PROPERLY, DESPITE IT BEING USED CORRECTLY. PICC WAS PLACED BEDSIDE. ON THE INSERTION, AS THE CATHETER WAS THREADED INTO THE SVC, IT BEGAN SHOWING BIPHASIC P-WAVES THAT MINIMIZED IN DEFLECTIONS AS THE PICC CONTINUED TO THREAD TOWARDS THE CAJ. ONCE THE PICC WAS AT THE MEASURED LENGTH, IT REFLECTED MAXIMUM PEAKED P-WAVES WITH NO DEFLECTION. I HAD THE INSERTER PUSH THE CATHETER IN FARTHER TOWARDS THE HUB, AND THE P-WAVES BECAME SMALLER WITH NO DEFLECTIONS. AS WE PULLED BACK ON THE CATHETER BEYOND MEASURED LENGTH, IT BEGAN TO SHOW DEFLECTIONS. IT WAS AS IF THE TECHNOLOGY WAS READING THE INTERPRETATION BACKWARDS. I HAD THE INSERTER LEAVE THE PICC AT THE MEASURED LENGTH WITH THE PEAKED P-WAVES AND ORDER A CHEST X-RAY, WHICH CONFIRMED PICC TIP PLACEMENT IN PERFECT POSITION AT SVC/CAJ. I COULD NOT TROUBLESHOOT THROUGH THIS TECHNICAL ISSUE AS THE TECHNOLOGY WAS SET UP PERFECT EXTERNALLY WITH THE LEADS AND POSITIONING OF THE SHERLOCK. ON A FEW OCCASIONS WE DID LOSE THE RHYTHMS (INTERNAL AND EXTERNAL) ON THE SCREEN, CHECKED CONNECTIONS WHICH APPEARED ALL INTACT, ¿JIGGLED¿ THE SHERLOCK A LITTLE, AND THEN THE CAME BACK. PATIENT DID NOT PRESENT WITH ANY CARDIAC ABNORMALITIES; SHE WAS IN NORMAL SINUS RHYTHM. THEY DENY DROPPING THE SHERLOCK ANYTIME OR KNOWING OF IT BEING ¿DAMAGED¿.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE P-WAVE TECHNOLOGY WAS NOT CONSISTENTLY CAPTURING THEIR PEAKED P-WAVES ACCURATELY, CAUSING THEM TO LEAVE TOO MUCH EXTERNAL LENGTH OR ADVANCING TOO FAR IN WITH CATHETER ON THE SMALL TABLET. SAID TECHNOLOGY WAS INCONSISTENT CONFIRMING PLACEMENT, AS SOMETIMES IT WOULD WORK PROPERLY. BUT DUE TO THEIR LACK OF CONFIDENCE IN THE TECHNOLOGY, THEY STILL ORDERED CXR TO CONFIRM TIP PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777438 SHERLOCK 3CG PLUS TCS CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A N/A 00801741163029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other