BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORP.

    MDR report key: 678848 · Received November 11, 2005

    Report

    Report Number
    1317056-2005-00062
    Event Type
    Malfunction
    Date Received
    November 11, 2005
    Date of Event
    October 10, 2005
    Report Date
    October 19, 2005
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY END USER HOSPITAL, THE TUBING FROM THE VENTED DRIP CHAMBER OF A FLUID DELIVERY SET IS KINKED, MAKING IT DIFFICULT TO DRAW CONTRAST MEDIA AND CREATING MICROBUBBLES. THERE HAS BEEN NO PT INJURY. A SAMPLE IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP. 72" FLUID DELIVERY SET WITH DRIP CHAMBER FPA BOSTON SCIENTIFIC/NAMIC NA 594376

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN