BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS DEVICE

    MDR report key: 38098 · Received September 11, 1996

    Report

    Report Number
    1219454-1996-00409
    Event Type
    Injury
    Date Received
    September 11, 1996
    Date of Event
    May 10, 1996
    Report Date
    September 11, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 8/19/96, DURING A FOLLOW-UP CALL WITH THE FACILITY OR NURSE, THE MFR WAS INFORMED THAT THERE WERE TWO INCIDENTS INVOLVING THIS PT. THIS REPORT INVESTIGATES THE FIRST INCIDENT (SEE MFR 1219454-1996-00400 FOR ADD'L INFO REGARDING THE PT'S 2ND DEVICE). THE FACILITY OR NURSE STATED THAT THIS WAS A "STRANGE SITUATION" WHERE THE PT HAS RECENTLY RECEIVED HER 3RD IMPLANTED DEVICE. THE FIRST DEVICE WAS STATED TO HAVE BEEN IMPLANTED ON 3/14/95, AND IS ASSUMED TO HAVE BEEN REMOVED DUE TO THE SAME TYPE OF PROBLEM: LEAKING AND SPLIT OF THE DEVICE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS DEVICE Implant VASCULAR ACCESS DEVICE LJT STRATO/INFUSAID, INC. NA 12991

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention