BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS SOFT FLOW CANNULA

    MDR report key: 104167 · Received July 8, 1997

    Report

    Report Number
    1828100-1997-00012
    Event Type
    Malfunction
    Date Received
    July 8, 1997
    Date of Event
    June 9, 1997
    Report Date
    July 8, 1997
    Manufacturer
    3M HEALTH CARE SARNS AND CDI PRODUCTS
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER INSERTION OF THE CANNULA INTO THE PT'S AORTA, IT WAS NOTICED THAT THE TIP OF THE DEVICE WAS MISALIGNED BY 180 DEGREES WITH RESPECT TO THE REFERENCE LINE ON THE CANNULA TUBING. UPON THIS DISCOVERY, THE SURGEON ROTATED THE CANNULA SUCH THAT THE TIP WAS FACING IN THE PROPER DIRECTION WITH RESPECT TO THE PT'S AORTA. NO PT INJURY HAS BEEN REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS SOFT FLOW CANNULA ARTERIAL CANNULA DWF 3M HEALTH CARE SARNS AND CDI PRODUCTS 98-0702-1080-6 W350831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention