BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 189007 · Received September 24, 1998

    Report

    Report Number
    1220923-1998-00092
    Event Type
    Injury
    Date Received
    September 24, 1998
    Date of Event
    July 8, 1998
    Report Date
    July 22, 1998
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 8/28/98, THE MFR REC'D MEDWATCH REPORT 301 594 0004 98 FROM THE FACILITY THAT STATES THE FOLLOWING: AT CHEST X-RAY IT WAS FOUND THAT THE DEVICE TIP HAD BROKEN OFF. (THIS DEVICE WAS INSERTED 3/17/98). ON 7/9/98 THE DISTAL TIP OF THE DEVICE WAS REMOVED FROM THE VENA CAVA TRANSLUMINALLY. ON 7/16/98 THE REMAINDER OF THE DEVICE WAS REMOVED. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM Implant VASCULAR ACCESS DEVICE LJT STRATO/INFUSAID, INC. NA 14303

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention