BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPUT INTRODUCER

    MDR report key: 183038 · Received August 13, 1998

    Report

    Report Number
    1217435-1998-00211
    Event Type
    Malfunction
    Date Received
    August 13, 1998
    Report Date
    July 21, 1998
    Manufacturer
    C.R. BARD GALWAY LTD.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING THE PROCEDURE THIS DEVICE LEAKED. REPORTEDLY, THE LEAK OCCURRED AT THE SIDE ARM OF THE DEVICE. THE DEVICE WAS REMOVED & REPLACED. THE PT IS REPORTED AS FINE & THE DEVICE IS BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INPUT INTRODUCER CATHETER INTRODUCER DYB C.R. BARD GALWAY LTD. NA 44EIU123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN