BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN CV CATHETER, DUAL-LUMEN, 7F

    MDR report key: 24493276 · Received March 3, 2026

    Report

    Report Number
    3006260740-2026-01322
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 4, 2026
    Report Date
    May 7, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K830256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE HICKMAN CV CATHETER, DUAL-LUMEN, 7F PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE HICKMAN CV CATHETER, DUAL-LUMEN, 7F PRODUCTS ARE IDENTIFIED IN D2 AND G4. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE HICKMAN CV CATHETER, DUAL LUMEN, 7F PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE HICKMAN CV CATHETER, DUAL LUMEN, 7F PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT. INVESTIGATION SUMMARY: ONE 7FR HICKMAN D/L CATHETER IN THREE SEGMENTS WERE RETURNED FOR SAMPLE EVALUATION. GROSS, VISUAL, MICROSCOPIC VISUAL, TACTILE AND FUNCTIONAL EVALUATIONS WERE PERFORMED. A COMPLETE COMPOUND BREAK WAS NOTED ON THE DISTAL END OF THE CATHETER SEGMENT AND PROXIMAL END OF THE DISTAL CATHETER SEGMENT. THE EDGES OF THE COMPLETE COMPOUND BREAK ON THE DISTAL END OF THE CATHETER SEGMENT AND PROXIMAL END OF THE DISTAL CATHETER SEGMENT WERE NOTED TO BE UNEVEN, AND SURFACE NOTED TO BE GRANULAR. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED CATHETER BROKE OFF ISSUE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. B5, G3, H6 (COMPONENT, METHOD, RESULT, CONCLUSION) 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 CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER INTO THE RIGHT INTERNAL JUGULAR VEIN DURING A COMPLEX SURGICAL PROCEDURE. POST THE PROCEDURE ON (B)(6) 2026, DURING THE EXPLANTATION OF THE CATHETER, THE CATHETER TIP DETACHED DESPITE EXTENSIVE AND CAREFUL DISSECTION PERFORMED BY THE CLINICAL TEAM. REPORTEDLY, ON (B)(6) 2026, INTERVENTIONAL RADIOLOGY SUBSEQUENTLY RETRIEVED THE DETACHED CATHETER TIP USING A 4 FR INTRODUCER SHEATH VIA THE RIGHT FEMORAL VEIN. THE PRODUCT DATA FOR THE MEDICAL DEVICE WERE NOT CLEARLY OR UNAMBIGUOUSLY DOCUMENTED. FOLLOWING AN INTERNAL INVESTIGATION, THE DEVICE COULD BE IDENTIFIED AS A HICKMAN CATHETER, 7.0 FR, DOUBLE LUMEN, 65 CM, PERCUTANEOUS EFB. CUSTOMER MATERIAL NUMBER: 0600570CE; MATERIAL NUMBER: 10166824; ITEM BARCODE: 060057. BASED ON AN EVALUATION OF INCOMING GOODS RECORDS, THE BATCH NUMBER IS MOST LIKELY HUJT1687 (INFORMATION WITHOUT GUARANTEE). THE CATHETER, INCLUDING THE DETACHED CATHETER TIP AND THE Y-CONNECTOR, WAS RETRIEVED AND IS AVAILABLE FOR COLLECTION AND MATERIAL ANALYSIS. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER INTO THE RIGHT INTERNAL JUGULAR VEIN DURING A COMPLEX SURGICAL PROCEDURE. POST THE PROCEDURE ON (B)(6) 2026, DURING THE EXPLANTATION OF THE CATHETER, THE CATHETER TIP DETACHED DESPITE EXTENSIVE AND CAREFUL DISSECTION PERFORMED BY THE CLINICAL TEAM. REPORTEDLY, ON (B)(6) 2026, INTERVENTIONAL RADIOLOGY SUBSEQUENTLY RETRIEVED THE DETACHED CATHETER TIP USING A 4 FR INTRODUCER SHEATH VIA THE RIGHT FEMORAL VEIN. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585263 HICKMAN CV CATHETER, DUAL-LUMEN, 7F CHRONIC CATHETERS LJS C.R. BARD, INC. (BASD) -3006260740 HUJT1687

    Patients

    Seq Age Sex Outcome Treatment
    1