BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOFLO

    MDR report key: 24679687 · Received March 24, 2026

    Report

    Report Number
    2020394-2026-00702
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    February 28, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    UDI-DI
    00801741021350
    PMA / PMN Number
    K004011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, VIDEO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B (DYF; DSY). 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.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE BY USING THE CARBOFLO GRAFT. IT WAS REPORTED THAT DURING THE PROCEDURE, AT THE TIME OF SURGERY, THE IMPLANTED GRAFT WAS ALLEGEDLY OBSERVED TO BE POROUS AND LEAKING BLOOD. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27046 CARBOFLO EPTFE VASCULAR GRAFT DSY BARD PERIPHERAL VASCULAR, INC. VTKT0073 00801741021350

    Patients

    Seq Age Sex Outcome Treatment
    1