BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORP

    MDR report key: 678054 · Received July 13, 2005

    Report

    Report Number
    1317056-2005-00035
    Event Type
    Malfunction
    Date Received
    July 13, 2005
    Date of Event
    June 3, 2005
    Report Date
    June 15, 2005
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AIR COULD NOT BE ELIMINATED FROM THE TUBING OF A CONVENIENCE KIT DURING PREPARATION FOR A PROCEDURE. THE KIT WAS NOT USED AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP CONVENIENCE KIT DTL BOSTON SCIENTIFIC/NAMIC NA 590984

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN