BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVERTY TIPS ACCESS SET

    MDR report key: 23628887 · Received November 24, 2025

    Report

    Report Number
    2020394-2025-01926
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 31, 2025
    Report Date
    January 8, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    DYB
    UDI-DI
    00382903064663
    PMA / PMN Number
    K221440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THE SITE LEGAL NAME (FDA) FOR THE LIVERTY TIPS ACCESS SET PRODUCT WAS SELECTED AS BARD PERIPHERAL VASCULAR, INC, - TEMPE, AZ/85281 DUE TO SYSTEM LIMITATIONS. THE CORRECT SITE LEGAL NAME (FDA) FOR THE LIVERTY TIPS ACCESS SET IS BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU - SUZHOU, CHINA / 215126. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORD WAS NOT REQUESTED SINCE THE PROVIDED LOT NUMBERS WAS UNKNOWN. INVESTIGATION SUMMARY: ONE STEERABLE CANNULA WAS RECEIVED FOR EVALUATION. PRODUCT PACKAGING AND LABEL WERE NOT RETURNED. A PARTIAL CIRCUMFERENTIAL BREAK WAS OBSERVED ON THE DISTAL PORTION OF THE STEERING CANNULA. NO OTHER ANOMALIES WERE OBSERVED. UPON INSPECTING THE STEERING CANNULA KNOB, THE BLACK BAR ON THE KNOB WAS ALIGNED TO THE TOP PORTION OF THE ARROW BASE PLATE. THE BLACK BAR ON THE KNOB WAS ALIGNED TO THE TOP PORTION OF THE ARROW BASE PLATE; IT IS POSSIBLE THAT THE ROTATION ANGLE EXCEEDED 75°. EXCESSIVE ROTATION COMBINED WITH HIGH LIVER TISSUE RESISTANCE DURING USE MAY LEAD TO STEERABLE CANNULA BREAKAGE. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FRACTURE ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. G3, H6 (RESULT, CONCLUSION). SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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: THE SITE LEGAL NAME (FDA) FOR THE LIVERTY TIPS ACCESS SET PRODUCT WAS SELECTED AS (B)(6). DUE TO SYSTEM LIMITATIONS. THE CORRECT SITE LEGAL NAME (FDA) FOR THE LIVERTY TIPS ACCESS SET IS (B)(6). AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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 PROCEDURE USING TRANS JUGULAR LIVER ACCESS SET. DURING THE PROCEDURE. THE ADJUSTABLE TIP OF THE DEVICE FRACTURED DURING CANNULA ROTATION PRIOR TO TIPS PUNCTURE. THIS REQUIRED DELICATELY REMOVING THE FRACTURED CANNULA AND USING A NEW KIT. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING TRANS JUGULAR LIVER ACCESS SET. DURING THE PROCEDURE, THE ADJUSTABLE TIP OF THE DEVICE FRACTURED DURING CANNULA ROTATION PRIOR TO TIPS PUNCTURE. THIS REQUIRED DELICATELY REMOVING THE FRACTURED CANNULA AND USING A NEW KIT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390365 LIVERTY TIPS ACCESS SET INTRODUCER, CATHETER DYB BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU UNKNOWN 00382903064663

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male