BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOFT-CELL PC DIALYSIS CATHETER KIT 12.5F X 19 CM

    MDR report key: 4924280 · Received July 16, 2015

    Report

    Report Number
    3006260740-2015-00323
    Event Type
    Death
    Date Received
    July 16, 2015
    Date of Event
    June 20, 2015
    Report Date
    June 25, 2015
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LFJ
    PMA / PMN Number
    K871488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 TO ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED AND THE CAUSE APPEARS TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS ON 19CM SOFT-CELL DUAL LUMEN CATHETER. INITIAL EXAMINATION OF THE SAMPLE REVEALED USAGE RESIDUE THROUGHOUT. THE SAMPLE WAS RECEIVED WITH BOTH EXTENSION LEGS DETACHED NEAR THE BIFURCATION, WITH SMALL SEGMENTS OF EXTENSION TUBING REMAINING ATTACHED TO THE BIFURCATION. ALL SEGMENTS OF THE SAMPLE WERE PATENT TO INFUSION USING WATER FROM A 12ML SYRINGE, WITH NO LEAKS FOUND WHEN PRESSURIZED. MICROSCOPE EXAMINATION OF THE TERMINAL ENDS OF THE EXTENSION TUBING OF THE SAMPLE REVEALED SURFACES THAT WERE REFLECTIVE IN NATURE AND CONTAINED LINEAR STRIATION-LIKE PATTERNS WHICH GENERALLY TRENDED TOWARDS THE CENTER OF THE LUMEN. THE DAMAGE WAS ALSO SYMMETRICAL ABOUT TWO STEPS/BUMPS IN THE TUBING (BOTH APPROXIMATELY 18 DEGREES FROM EACH OTHER). THE STRIATION PATTERNS WERE PERPENDICULAR TO THE STEPS/BUMS. THE RADIALLY ALIGNED STRIATIONS, AND THE STEPS/BUMPS, ARE CONSISTENT WITH DAMAGE CAUSED BY SCISSOR CONTACT. SCISSOR BLADES ARE COMMONLY SHARPENED BY GRINDING THE CUTTING EDGES, AND THIS PATTERN IS THEN TRANSFERRED TO THE CATHETER/EXTENSION TUBING MATERIAL DURING THIS TYPE OF CONTACT. SHEARING ACTION ALSO TRANSFERS TWO STEPS/BUMPS (APPROXIMATELY 180 DEGREES FROM EACH OTHER) ON THE CATHETER/EXTENSION TUBING AS WELL. AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO THE MANUFACTURE OF THE PRODUCT. A WARNING REGARDING ACCIDENTAL DEVICE CONTACT WITH A SHARP INSTRUMENT IS PROVIDED IN THE IFU. NO OTHER COMPLAINTS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE SOFT CELL WAS PLACED IN A(B)(6) PATIENT WITH DEMENTIA. ON THE DAY OF THE INSERTION AND THE FOLLOWING DAY, NO ISSUE WAS NOTED DURING DIALYSIS TREATMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WENT BACK TO THE SENIOR CARE FACILITY WHERE SHE LIVED. ON (B)(6) THE PATIENT REPORTEDLY BLED FROM THE BROKEN SITE OF THE CATHETER AND THE HEAVY HEMORRHAGE ALLEGEDLY CAUSED HER TO EXPIRE. ACCORDING TO THE VIEW OF THE DOCTOR, THE PATIENT HAD DEMENTIAL AND WAS SUSPECTED TO FORCIBLY TUG AT / CUT THE CATHETER BY HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463867 SOFT-CELL PC DIALYSIS CATHETER KIT 12.5F X 19 CM LFJ BARD ACCESS SYSTEMS REYC1806

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death