BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTROVENA ONE

    MDR report key: 24688277 · Received March 25, 2026

    Report

    Report Number
    3006260740-2026-01982
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 27, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    SEF
    UDI-DI
    00801741234729
    PMA / PMN Number
    K242429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 COMPLAINT OF A BLUNTED NEEDLE TIP WAS CONFIRMED; HOWEVER, THE ROOT CAUSE WAS NOT IDENTIFIED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE CENTROVENA ONE CATHETER INSERTION ASSEMBLY AND ONE 7FR BY 20CM CENTRAL VENOUS CATHETER. THE GUIDEWIRE WAS REMOVED FROM THE NEEDLE. THE SHEATH WAS CUT AND THE SAFETY MECHANISM WAS ENGAGED OVER THE NEEDLE TIP. BLOOD RESIDUE WAS OBSERVED THROUGHOUT THE DISTAL REGION OF THE NEEDLE AND SHEATH. A PORTION OF THE TIP OF THE SHEATH WAS TORN AND FOLDED BACKWARD. THIS DAMAGE IS ADDRESSED IN TRACKWISE COMPLAINT 14404763. THE NEEDLE TIP APPEARED BLUNTED. MICROSCOPIC INSPECTION OF THE SAMPLE CONFIRMED NEEDLE TIP DAMAGE. THE TIP OF THE NEEDLE EXHIBITED DEFORMATION CONSISTENT WITH A FACTURE, LEAVING THE NEEDLE TIP FLAT (SEE ATTACHED PHOTOGRAPHS). MICROSCOPIC INSPECTION OF THE METAL SAFETY TIP SHIELD REVEALED LIGHT SCORING MARKS, SUGGESTING SOME CONTACT WITH THE NEEDLE TIP. INSPECTION OF THE NEEDLE TIP REVEALED THAT IT APPEARED TO HAVE FRACTURED; HOWEVER, NO EVIDENCE WAS OBSERVED THAT INFORMED PRECISELY WHEN OR HOW THAT FRACTURE OCCURRED. CONSEQUENTLY, THIS COMPLAINT IS CONFIRMED AS ¿CAUSE UNKNOWN¿ AT THIS TIME. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    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 FAILURE WAS FOUND DURING EVALUATION OF A RETURNED SAMPLE. ADDITIONAL INVESTIGATION IS REQUIRED TO DETERMINE THE CAUSE OF THE FAILURE. RESULTS OF THE INVESTIGATION ARE EXPECTED SOON.

    Description of Event or Problem · 0

    IT WAS FOUND DURING A SAMPLE INVESTIGATION THAT THE NEEDLE TIP APPEARED DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136279 CENTROVENA ONE CENTRAL VENOUS CATHETERIZATION KIT, SHORT-TERM SEF C.R. BARD, INC. (BASD) -3006260740 NA REKY2340 00801741234729

    Patients

    Seq Age Sex Outcome Treatment
    1