BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER

    MDR report key: 18977488 · Received March 26, 2024

    Report

    Report Number
    3006260740-2024-01276
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    March 4, 2024
    Report Date
    June 7, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741086991
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 COMPLAINT OF A LEAK IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE VIDEO OF A GROSHONG CATHETER WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE VIDEO SHOWED BUBBLES AS THE CATHETER WAS ASPIRATED; HOWEVER, NO DAMAGE OR OTHER EVIDENCE OF THE APPARENT LEAK COULD BE SEEN IN THE CATHETER TUBING IN THE RETURNED VIDEO. THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED VIDEO OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Additional Manufacturer Narrative · 0

    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 0

    IT WAS REPORTED, "THERE ARE BUBBLES IN THE GRO RETRACTION, AND THERE IS A LEAKAGE POINT IN THE LEAKAGE PART, SO THE CATHETER CANNOT BE USED AFTER ONE DAY OF IMPLANTATION." NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED, "THERE ARE BUBBLES IN THE GRO RETRACTION, AND THERE IS A LEAKAGE POINT IN THE LEAKAGE PART, SO THE CATHETER CANNOT BE USED AFTER ONE DAY OF IMPLANTATION." NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434095 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REGZ0085 00801741086991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other