BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG 9.5 FR D/L CATHETER

    MDR report key: 171645 · Received June 4, 1998

    Report

    Report Number
    1720496-1998-00175
    Event Type
    Malfunction
    Date Received
    June 4, 1998
    Date of Event
    April 29, 1998
    Report Date
    May 5, 1998
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLICATED PRODUCT IS A 9.5 FR. DUAL LUMEN CATHETER WITH TISSUE INGROWTH CUFF IN A PEEL-APART PERCUTANEOUS INTRODUCER SYSTEM. PRODUCT RECEIVED FOR EVALUATION IS 9.5 FR. DUAL LUMEN CATHETER. COMPLETE CATHETER, WITH CONNECTORS INSERTED IN EACH EXTENSION LEG MEASURES 25.2 INCHES LONG. A SINGLE, MONOFILAMENT SUTURE IS TIED AROUND THE CATHETER APPROXIMATELY 0.5 INCHES DISTAL TO THE STRAIN RELIEF. A SMALL, "U" SHAPED PENETRATION IS NOTED IMMEDIATELY PROXIMAL TO TISSUE INGROWTH CUFF. CUFF IS CLEAN AND FREE OF DAMAGE. DRIED BLOOD NOTED WITHIN CATHETER'S DISTAL LUMEN. LOT HISTORY REVIEW REVEALS NO RELATED MANUFACTURING ISSUES AND NO OTHER COMPLAINTS FOR THIS LOT. TACTUAL EXAMINATION EXAGGERATES THE "U" SHAPED PENETRATION NEAR THE CUFF AS WELL AS IDENTIFIES DENSITIES WITHIN CATHETER LUMEN CAUSED BY DRIED BLOOD. EXAMINATION OF "U" SHAPED PENETRATION IS ACCOMPLISHED USING 5X-15X MAGNIFICATION. BASE OF "U" FOLLOWS CATHETER'S LONGITUDINAL PLANE. WHILE THE BASE OF "U" IS ONLY APPROXIMATELY 0.1 INCH LONG, IT IS SLIGHTLY LONGER THAN PERPENDICULAR SIDES. EDGES OF "U" ARE WELL DEFINED & APPEAR TO PENETRATE COMPLETELY THROUGH CATHETER WALL AT STEEP ANGLE. TUBING WALLS ARE FLAT & SMOOTH. THESE TRAITS ARE CHARACTERISTIC IN BURST TRAUMA SECONDARY TO OVER-PRESSURIZATION. NO OTHER DAMAGE IS NOTED THROUGHOUT CATHETER'S LENGTH. DISTAL VALVE WALLS ARE GAPPED SLIGHTLY AS DRIED BLOOD FILLS DISTAL 1 INCH OF LUMEN. PATENCY TESTING IS ACCOMPLISHED BY ATTEMPTING TO FLUSH WATER THROUGH EACH LUMEN INDIVIDUALLY WITH 10CC SYRINGE. PROXIMAL (WHITE LUER) LUMEN IS PATENT TO BOTH FLUSHING & ASPIRATING. DISTAL (RED LUER) IS OCCLUDED. COMPLAINT OF SUBCUTANEOUS LEAK IS CONFIRMED, USER-RELATED. DAMAGE ADJACENT TO COMPLAINT SAMPLE'S TISSUE INGROWTH CUFF IS CONSISTENT WITH BURST TRAUMA SECONDARY TO OVER-PRESSURIZATION. OVER-PRESSURIZATION CAN RESULT FROM A NUMBER OF CAUSES INCLUDING AN OCCLUDED LUMEN. THE PRODUCT INSTRUCTIONS FOR USE RECOMMEND NOT EXCEEDING 25 PSI DURING FLUID ADMINISTRATION TO PREVENT DAMAGE TO CATHETER & PATIENT.

    Description of Event or Problem · 1

    THE CATHETER WAS LEAKING AROUND THE CUFF, REMOVED & REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG 9.5 FR D/L CATHETER LONG TERM INTRAVASCULAR CATHETER DQO BARD ACCESS SYSTEMS 7726950 36LH4495

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention