BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTROVENA ONE

    MDR report key: 24583644 · Received March 12, 2026

    Report

    Report Number
    3006260740-2026-01571
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 26, 2026
    Report Date
    May 11, 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 DIFFICULT CENTOVENA ONE INSERTION 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. MICROSCOPIC INSPECTION OF THE SAMPLE CONFIRMED DEFORMATION AT THE DISTAL TIP OF THE SHEATH. TWO PARALLEL, LONGITUDINALLY ALIGNED SPLIT WERE OBSERVED, CORRESPONDING TO THE WIDTH OF THE NEEDLE CHANNEL. THE SPLITS RESULTED IN A FLAP OF SHEATH MATERIAL THAT PEELED AWAY FROM THE NEEDLE. THE TIP OF THE SHEATH APPEARED WELL-FORMED. THE SPACING BETWEEN THE TWO LONGITUDINAL SPLITS SUGGESTED THAT BUCKLING OCCURRED WHERE THE NEEDLE SLOT LEAVES THE SHEATH WITHOUT SUPPORT. SUCH DAMAGE MAY OCCUR IF THE GUIDEWIRE IS NOT WITHDRAWN INTO THE NEEDLE SHAFT PRIOR TO INSERTION. THE PRODUCT IFU STATES ¿FAILURE TO RETRACT THE GUIDEWIRE INTO THE NEEDLE MAY RESULT IN DAMAGE TO THE INTEGRATED SHEATH.¿

    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED, PATIENT WOULDN¿T LAY FLAT- PROPPED UP DUE TO CONDITION. THEY TRIED AXILLARY SUBCLAVIAN- IJ NOT AVAILABLE DUE TO TUBING ETC COULDN¿T ACCESS. HE WAS HAVING TROUBLE GETTING NEEDLE THROUGH VEIN- COULD SEE THE VEIN AND ARTERY ON ULTRASOUND BUT NEEDLE WOULDN¿T PENETRATE THE VEIN. HE PULLED BACK AND TRIED TO REINSERT IN THE VEIN AND THEN HE REMOVED THE CATHETER COMPLETELY- WHEN HE PULLED IT BACK HE SAW THE BUR. HE TRIED TO THREAD THE GUIDEWIRE AND HE MET RESISTANCE. AFTER HE MET RESISTANCE HE PULLED THE GUIDEWIRE BACK, TRIED TO REPOSITION THE NEEDLE A LITTLE BIT. CLINICIAN INSERTED NEEDLE AND WAS HAVING ISSUES GETTING THROUGH TISSUE. PROCEEDED TO INSERT AND ENCOUNTERED ISSUES THREADING GUIDEWIRE. SECOND INSERTION WAS A BREEZE- DIDN¿T USE THE SAME PUNCTURE SITE BUT WAS NEAR. NO PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612319 CENTROVENA ONE CENTRAL VENOUS CATHETER (CVC) SEF C.R. BARD, INC. (BASD) -3006260740 N/A REKY2340 00801741234729

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Other