BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC/NAMIC

    MDR report key: 615953 · Received June 2, 2005

    Report

    Report Number
    1317056-2005-00017
    Event Type
    Malfunction
    Date Received
    June 2, 2005
    Date of Event
    May 5, 2005
    Report Date
    May 5, 2005
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY HOSPITAL A CONTRAST INJECTING FITTING DETACHED DURING A POWER INJECTION RESULTING IN CONTRAST SPRAY. FITTING COULD NOT BE DETACHED FROM CATHETER, SO CATHETER AS WELL AS CIL HAD TO BE REPLACED DURING PROCEDURE. THERE WAS NO PATIENT INJURY. A SAMPLE IS EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC/NAMIC 48" HIGH PRESSURE CONTRAST INJ. LINE DXT BOSTON SCIENTIFIC/NAMIC NA 1036095

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN