BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC CUSHION NASAL CANNULA

    MDR report key: 6085085 · Received November 8, 2016

    Report

    Report Number
    6085085
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 1, 2016
    Manufacturer
    CAREFUSION 211, INC., DBA CAREFUSION
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EMERGENCY DEPARTMENT REPORTED A PEDIATRIC NASAL CANNULA COMING OUT OF THE PACKAGE WITH A WHITE, SOME-WHAT GREASY FILM ON THE TUBING. NOT SURE IF THIS IS A MANUFACTURING BY-PRODUCT OR WHAT, BUT IT WAS FELT THAT THIS SHOULD BE REPORTED. THE ISSUE WAS FOUND BEFORE THE DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737447 PEDIATRIC CUSHION NASAL CANNULA CANNULA, NASAL, OXYGEN CAT CAREFUSION 211, INC., DBA CAREFUSION 0000902801

    Patients

    Seq Age Sex Outcome Treatment
    1