BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PROVENA CATHETER

    MDR report key: 18481145 · Received January 9, 2024

    Report

    Report Number
    3006260740-2024-00046
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 19, 2023
    Report Date
    January 8, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT "ISSUE WITH 3FR PROVENA CATHETER WHERE WE PLACED THE LINE WITHOUT ISSUE AND UPON OUR INITIAL CHECK FOR BLOOD RETURN AFTER REMOVING THE GUIDEWIRE, WE HAVE BLOOD RETURN HOWEVER BY THE TIME WE PLACE OUR DRESSING AND DO THE FINAL CHECK, WE NO LONGER HAVE BLOOD RETURN OR SHORTLY AFTER, WE ARE TOLD IT NO LONGER FLUSHES OR HAS BLOOD RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682879 BARD PROVENA CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other