BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC PROVENA 3F SL MBPLUS (3CG, BIOPATCH, PROBE COVER)

    MDR report key: 18243295 · Received November 30, 2023

    Report

    Report Number
    3006260740-2023-05444
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 12, 2023
    Report Date
    January 10, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741155031
    PMA / PMN Number
    K180548
    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.

    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. INITIAL MEDWATCH REPORT WAS SUBMITTED, UPON FURTHER REVIEW IT WAS FOUND THAT THIS MEDWATCH REPORT 3006260740-2023-05444 IS A DUPLICATE FILE AND HAS BEEN VOIDED. THE ORIGINAL EVENT WAS SUBMITTED ON MEDWATCH REPORT 3006260740-2024-00046.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT "WE HAVE BEEN HAVING SOME ISSUES WITH OUR 3FR PROVENA CATHETERS WHERE WE PLACE 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. IT HAS HAPPENED TWO TIMES IN THE PAST FEW WEEKS ON DIFFERENT TYPES OF PATIENTS." THIS REPORT ADDRESSES THE SECOND EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT "WE HAVE BEEN HAVING SOME ISSUES WITH OUR 3FR PROVENA CATHETERS WHERE WE PLACE 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. IT HAS HAPPENED TWO TIMES IN THE PAST FEW WEEKS ON DIFFERENT TYPES OF PATIENTS." THIS REPORT ADDRESSES THE SECOND EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592702 POWERPICC PROVENA 3F SL MBPLUS (3CG, BIOPATCH, PROBE COVER) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REHU0949 00801741155031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other