BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY

    MDR report key: 19509228 · Received June 11, 2024

    Report

    Report Number
    3006260740-2024-02928
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 15, 2024
    Report Date
    May 17, 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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER AFTER USING THE GRO IN THE PATIENT'S BODY FOR 1 WEEK, THE PUNCTURE POINT WAS FOUND TO BE OOZING DURING MAINTENANCE, AND THE CATHETER WAS WITHDRAWN ABOUT 3 CM OUTWARD, AND THE LEAKAGE PROBLEM WAS FOUND. BECAUSE THE PATIENT DID NOT AGREE TO RETUBING, THE EXTENSION TUBE WAS RECONNECTED AND USED AFTER THE END LEAK WAS CUT OFF. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED THREE TIMES. THIS REPORT ADDRESSES THE FIRST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814840 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REDS2273 00801741086991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other