BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YANKAUER FINE FLX W/O TROL/SUMP

    MDR report key: 6121739 · Received November 22, 2016

    Report

    Report Number
    9611018-2016-00058
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    June 28, 2016
    Report Date
    November 1, 2016
    Manufacturer
    COVIDIEN
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/22/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 11/01/2016 THAT A CUSTOMER HAD AN ISSUE WITH A YANKAUER SUCTION INSTRUMENT. THE CUSTOMER REPORTS THAT THE LUMEN OF THE CANNULA IS SMALLER THAN USUAL. THE PHYSICIAN COULDN'T CLEAR OUT EVEN WITH A SMALL INSTRUMENT, THEREFORE THE DEVICE COULD NOT SUCTION PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770908 YANKAUER FINE FLX W/O TROL/SUMP YANKAUER SUCTION INSTRUMENT JOL COVIDIEN 8888504001 16D273FHX

    Patients

    Seq Age Sex Outcome Treatment
    1