BEUDAMED
    FDA Adverse Event Summary report: N

    HEMED REPAIR KIT, 1.0 MM

    MDR report key: 11832 · Received March 3, 1994

    Report

    Report Number
    MW1000951
    Date Received
    March 3, 1994
    Date of Event
    March 1, 1994
    Report Date
    March 2, 1994
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    DQO
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ORIGINAL CATHETER WAS PLACED ON 5/12/93. THE BLUE LUMEN WAS REPAIRED ON 5/13/93 AND AGAIN ON 12/20/93, APPROX 3 INCHES BELOW THE ORIGINAL REPAIR. ON 3/1/94, PT REPORTED LEAKING FROM THE CATHETER. THE FIRST REPAIR AREA HAD RUPTURED THE OUTER LUMEN JUST ABOVE THE NARROW END OF TAPERED BOOT FROM SECOND REPAIR. THE FIRST REPAIR AREA SHOWS A SLIT ALONG OUTER LUMEN. THE INNER LUMEN WAS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMED REPAIR KIT, 1.0 MM DQO GISH BIOMEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *