BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTROVENA ONE

    MDR report key: 25104154 · Received May 6, 2026

    Report

    Report Number
    3006260740-2026-03205
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 24, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    SEF
    UDI-DI
    00801741234729
    PMA / PMN Number
    K242429
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED NEEDLE STICK WHEN PLACING SUTURES. CLINICIAN WAS SENT FOR FOLLOW UP ACCORDING TO THEIR POLICY. PATIENT DID NOT HAVE ANY BLOOD BORNE DISEASES, AND NO ADVERSE EVENT OR SERIOUS INJURY TO PATIENT OR HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597019 CENTROVENA ONE CENTRAL VENOUS CATHETERIZATION KIT, SHORT-TERM SEF C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN 00801741234729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention