BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOFLO

    MDR report key: 22563434 · Received July 22, 2025

    Report

    Report Number
    2020394-2025-01068
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 24, 2025
    Report Date
    August 14, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    UDI-DI
    00801741021053
    PMA / PMN Number
    K004011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    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 WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. 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.

    Additional Manufacturer Narrative · 0

    H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE REPORTED LEAK ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELLING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. D2B (DYF; DSY), B5, G3, H6 (METHOD). 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) 2025, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE, THE GRAFT ALLEGEDLY LEAKING UP NORMALLY AT THE SITE OF STITCHING. PHYSICIAN HAD TO ADD PATCH THE SITE, TO STOP THE LEAK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE IN ILIAC TO POPLITEAL BYPASS GRAFT TO TREAT FEMORAL ISCHEMIA, THE GRAFT ALLEGEDLY LEAKING UP NORMALLY AT THE SITE OF STITCHING. PHYSICIAN HAD TO ADD PATCH THE SITE, TO STOP THE LEAK. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293706 CARBOFLO EPTFE VASCULAR GRAFT DSY BARD PERIPHERAL VASCULAR, INC. VTHY0506 00801741021053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male