BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 188602 · Received September 23, 1998

    Report

    Report Number
    1220923-1998-00091
    Event Type
    Injury
    Date Received
    September 23, 1998
    Date of Event
    July 1, 1998
    Report Date
    July 6, 1998
    Manufacturer
    STRATO/INFUSAID INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    ON 8/28/98, THE MFR REC'D MEDWATCH REPORT FDA ACCESS #1014124 FROM THE FDA THAT STATES THE FOLLOWING: PT RETURNS AFTER HAVING THE DEVICE INSERTED (6/2/98). IS RETURNING DUE TO LEAK IN THE DEVICE. AFTER REMOVING THE DEVICE, THREE VERTICAL SLICES NOTED IN THE DISTAL END OF THE CATHETER. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESS DEVICE LJT STRATO/INFUSAID INC. NA 13790

    Patients

    Seq Age Sex Outcome Treatment
    1