BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PH HANDLE FOR YANK SUCT DEVICE

    MDR report key: 475977 · Received August 4, 2003

    Report

    Report Number
    1423507-2003-00094
    Event Type
    Malfunction
    Date Received
    August 4, 2003
    Date of Event
    June 21, 2003
    Report Date
    August 4, 2003
    Manufacturer
    CARDINAL HEALTH
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN LPN WAS SUCTIONING A DYING RESIDENT USING THE YANKAUER SUCTION HANDLE WITH LAPERED BULBOUS TIP. THE RESIDENT BIT DOWN ON THE TIP AND A SMALL PIECE OF IT BROKE OFF. THE LPN WAS ABLE TO RETRIEVE THE PIECE OUT OF THE RESIDENT'S MOUTH AND NO HARM WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PH HANDLE FOR YANK SUCT DEVICE SUCTION HANDLE JOL CARDINAL HEALTH K80 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other