BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORP.

    MDR report key: 572381 · Received February 11, 2005

    Report

    Report Number
    1317056-2005-00004
    Event Type
    Malfunction
    Date Received
    February 11, 2005
    Date of Event
    January 13, 2005
    Report Date
    January 13, 2005
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE FILLING AN ANGIOGRAPHIC SYRINGE PACKAGE IN A CONVENIENCE KIT, THE PHYSICIAN NOTED AIR ENTERING AROUND THE O-RING IN THE ROTATING ADAPTOR OF THE SYRINGE. THE SYRINGE WAS NOT USED AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP. ANGIOGRAPHIC SYRINGE DXT BOSTON SCIENTIFIC/NAMIC NA 275141A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN