BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATHETER

    MDR report key: 32920 · Received May 9, 1996

    Report

    Report Number
    MW1009059
    Event Type
    Injury
    Date Received
    May 9, 1996
    Date of Event
    April 15, 1995
    Report Date
    April 30, 1996
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOME CARE PT DEVELOPED A LEAK IN CATHETER AND WHEN HOME CARE NURSE WAS UNABLE TO REMOVE CATHETER, PHYSICIAN WAS CALLED. ARRANGEMENTS WERE MADE FOR PT TO BE TAKEN TO HOSP AS AN OUTPATIENT THE NEXT MORNING (4/15) TO HAVE CATHETER REMOVED AND REPLACED. THIS WAS UNABLE TO BE DONE AND THE CATHETER HAD TO BE SURGICALLY REMOVED. PT HAD TO BE HOSPITALIZED OVERNIGHT FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATHETER INTRAVASCULAR CATHETER DQO LUTHER MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Hospitalization