BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORPORATION

    MDR report key: 536464 · Received March 18, 2004

    Report

    Report Number
    1317056-2004-00008
    Event Type
    Malfunction
    Date Received
    March 18, 2004
    Date of Event
    February 18, 2004
    Report Date
    February 18, 2004
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTS HOSPITAL COMPLAINING OF AIR ENTERING SYSTEM DURING HIGH PRESSURE INJECTIONS WITH LIEBEL-FLARSHEIM POWER INJECTOR. CONNECTION BETWEEN THE LIEBEL-FLARSHEIM SYRINGE AND THE FEMALE LUER LOCK ON THE CONTRAST INJECTION LINE IS BEING QUESITONED AS THE SOURCE OF AIR ENTRY. NO SAMPLE BEING RETURNED. THERE HAS BEEN NO PT INJURY OR INJECTION OF AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORPORATION 30" HIGH PRESSURE CONTRAST INJ. LINE DXT BOSTON SCIENTIFIC/NAMIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN