BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT DELRIN ATTACHABLE SYSTEM

    MDR report key: 40443 · Received September 27, 1996

    Report

    Report Number
    1219454-1996-00421
    Event Type
    Injury
    Date Received
    September 27, 1996
    Date of Event
    August 1, 1996
    Manufacturer
    STRATO/INFUSAID INC
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR RECEIVED THE DEVICE ON 9/11/96, FOR ANALYSIS AND THE RESULTS ARE AS FOLLOWS: VISUAL EXAM REVEALED A LARGE, DARK, AMBER COLORED PARTICLE UNDER THE DEVICE RESERVOIR. APPROX. TEN NEEDLE PENETRATION MARKS WERE SEEN CONCENTRATED IN THE CENTER OF THE DEVICE SEPTUM. THE TEN NEEDLE PENETRATION MARKS WERE SEEN EXTENDING INTO THE SILICONE MATERIAL OF THE DEVICE SEPTUM UNDER THE SURFACE, INTO THE LARGE, DARK, AMBER COLORED PARTICLE. THE DEVICE WAS PATENT UPON FLUSHING WITH NO RESISTANCE FELT AND APPROX. 5MLS OF CLEAR COLORLESS "PARTICLE FREE" FLUID WAS COLLECTED. A LEAK TEST CONFIRMED THAT THIS DEVICE DID NOT LEAK. THE LARGE, DARK, AMBER COLORED PARTICLE TESTED POSITIVE FOR BLOOD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND DID NOT REVEAL ANY TRENDS. BASED ON THE INFO AVAILABLE, THE CAUSE OF THE BLOOD FOUND IN THE DEVICE SEPTUM COULD NOT BE DETERMINED AND THE MD'S COMPLAINT OF "INABILITY TO FLUSH THE DEVICE AFTER IMPLANT", COULD NOT BE CONFIRMED. HOWEVER, IT IS POSSIBLE THAT THE LARGE BLOOD CLOT LOCATED IN THE CENTER OF THE DEVICE RESERVOIR MAY HAVE PARTIALLY AND/OR TOTALLY OCCLUDED THE DEVICE FLOW PATH. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ON 8/30/96, A MFR'S DIST REP CONTACTED THE MFR AND REPORTED THAT HE WAS PRESENT AT THE FACILITY WHEN MANAGER OF SURGICAL SERVICES PRESENTED HIM WITH THE DEVICE IN A STERILE RE-PACKAGE. THE FACILITY NURSE EXPLAINED THAT THE DEVICE WAS EXPLANTED BECAUSE THE PHYSICIAN COULD NOT FLUSH THE DEVICE AFTER IT WAS IMPLANTED. THE DIST REP REPORTED THAT WAS THE ONLY INFO WHICH WAS PROVIDED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT DELRIN ATTACHABLE SYSTEM Implant VASCULAR ACCESS SYSTEM LJT STRATO/INFUSAID INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention