BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTROVENA ONE

    MDR report key: 25302449 · Received May 27, 2026

    Report

    Report Number
    3006260740-2026-03671
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 12, 2026
    Report Date
    May 15, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    SEF
    UDI-DI
    00801741231353
    PMA / PMN Number
    K242429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTRODUCER/SHEATH SHEARED. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237005 CENTROVENA ONE CENTRAL VENOUS CATHETER SEF C.R. BARD, INC. (BASD) -3006260740 NA RELQ3491 00801741231353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other