BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORP

    MDR report key: 655495 · Received December 15, 2005

    Report

    Report Number
    1317056-2005-00068
    Event Type
    Malfunction
    Date Received
    December 15, 2005
    Date of Event
    November 18, 2005
    Report Date
    November 18, 2005
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY CUSTOMER, TUBINGS IN CONVENIENCE ANGIOGRAPHIC KIT ARE KINKED, ESPECIALLY ON THE TRANSDUCER-CREATING PROBLEMS WITH AIR IN THE SYSTEM. THERE HAS BEEN 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 1071907

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN