BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORP.

    MDR report key: 539724 · Received August 12, 2004

    Report

    Report Number
    1317056-2004-00025
    Event Type
    Malfunction
    Date Received
    August 12, 2004
    Date of Event
    July 6, 2004
    Report Date
    July 14, 2004
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY HOSP, WHEN UTILIZING A SYRINGE IN A CONVENIENCE KIT, THE SYRINGE ATTACHED TO THE MANIFOLD AT A SLIGHT ANGLE, AND ADMITTED AIR INTO THE SYSTEM. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP. 12CC ANGIOGRAPHIC SYRINGE DXT BOSTON SCIENTIFIC/NAMIC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN