BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YANKAUER SUCTION TIP

    MDR report key: 2455625 · Received February 13, 2012

    Report

    Report Number
    2455625
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 13, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THE SURGERY THE ANESTHESIOLOGIST WAS SUCTIONING THE PATIENT. AS HE WAS DOING THIS THE PATIENT BIT DOWN ON THE YANKUER SUCTION TIP. THE ANESTHESIOLOGIST PULLED OUT THE SUCTION TIP AND NOTICED THAT APPROXIMATELY 1 INCH WAS MISSING AND THE TIP WAS JAGGED AND SHARP. HE THEN PROCEEDED TO REPLACE SUCTION TIP WITH NEW ONE AND RE-SUCTIONED THE MOUTH AND THROAT. HE WAS ABLE TO RETRIEVE A FEW SMALL PIECES, HOWEVER HE FELT LIKE A PORTION WAS STILL NOT RETRIEVED.IN THE RECOVERY ROOM WHEN THE PATIENT WAS MORE AWAKE AND ABLE TO RESPOND APPROPRIATELY THE ANESTHESIOLOGIST LOOKED INTO THE PATIENT'S MOUTH WITH A LIGHT AND ASKED THE PATIENT IF HE COULD FEEL ANY THING IN HIS MOUTH OR THROAT. THE PATIENT DENIED FEELING ANYTHING FOREIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YANKAUER SUCTION TIP SUCTION TIP JOL CARDINAL HEALTH K61 0000356660

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR