BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMAQUET EXCEL

    MDR report key: 36858 · Received August 29, 1996

    Report

    Report Number
    1217435-1996-00013
    Event Type
    Malfunction
    Date Received
    August 29, 1996
    Date of Event
    August 2, 1996
    Report Date
    August 2, 1996
    Manufacturer
    USCI DIV. C.R. BARD, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC PROCEDURE THE VALVE OF THIS DEVICE LEAKED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMAQUET EXCEL CATHETER INTRODUCER DYB USCI DIV. C.R. BARD, INC. NA 11HF0851

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO