BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS HIGH FLOW AORTIC ARCH CANNULA, 20FR

    MDR report key: 56199 · Received December 12, 1996

    Report

    Report Number
    1828100-1996-00006
    Event Type
    Malfunction
    Date Received
    December 12, 1996
    Date of Event
    November 13, 1996
    Report Date
    December 12, 1996
    Manufacturer
    3M HEALTH CARE SARNS AND CDI PRODUCTS
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING DE-AIRING OF THE CIRCUIT, A SMALL PIECE OF PLASTIC WAS DISCOVERED IN THE CANNULA. NO PT PROBLEM HAS BEEN REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS HIGH FLOW AORTIC ARCH CANNULA, 20FR ARTERIAL CANNULA DWF 3M HEALTH CARE SARNS AND CDI PRODUCTS 98-0702-0043-6 A111795

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN