BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARACIL CONTRAST INJECTION LINE

    MDR report key: 102696 · Received June 30, 1997

    Report

    Report Number
    1317056-1997-00029
    Event Type
    Malfunction
    Date Received
    June 30, 1997
    Date of Event
    June 2, 1997
    Report Date
    June 2, 1997
    Manufacturer
    SCHNEIDER/NAMIC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END USER IS NEW TO USING THIS PRODUCT WITH A ROTATING ADAPTOR. THE CUSTOMER OBSERVED SEVERAL INCIDENTS OF MICRO AMD MACRO AIR BUBBLES APPEARING FROM THE CONNECTION OF THE ROTATING ADAPTOR AND MEDITECH 5F CATHETER PLASTIC HUB. END USER IS NOT PRESSURING FLUIDS, USING WARM CONTRAST AND CONNECTING WET TO WET. THE CUSTOMER STATED THAT IF PERFORMING A REAL SLOW ASPIRATION BY MEDRAD, THEY DO NOT SEE ANY BUBBLES. THE CUSTOMER STATED THAT THEY LIKE THEIR CURRENT TECHNIQUE WHICH SEEMS TO LEND ITSELF TO BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARACIL CONTRAST INJECTION LINE HIGH PRESSURE CONTRAST INJECTION LINE DXT SCHNEIDER/NAMIC NA 393507

    Patients

    Seq Age Sex Outcome Treatment
    1 NA