BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YANKAUER SUCTION TUBE W/SCREW TIP

    MDR report key: 384972 · Received March 28, 2002

    Report

    Report Number
    1423507-2002-00048
    Event Type
    Injury
    Date Received
    March 28, 2002
    Date of Event
    February 15, 2002
    Report Date
    March 28, 2002
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    KCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IN 2002, A PATIENT WAS SWITCHED FROM A PLASTIC YANKEUR TO A METAL YANKEUR BECAUSE THE PATIENT'S CONFUSED MENTAL STATE CREATED A RISK THAT PATIENT WOULD CHEW OFF THE TIP OF THE PLASTIC YANKEUR. THE PATIENT ASPIRATED THE SCREW OFF TIP OF THE METAL YANKEUR AND AN EMERGENCY BRONCHOSCOPY WAS PERFORMED TO REMOVE THE TIP FROM THE PATIENT'S LUNG. PATIENT SUFFERED NO ADVERSE CONSEQUENCES. FURTHER CONVERSATION WITH THE CUSTOMER REVEALED THAT THEY WERE NOT CERTAIN OF THE AGITATED PATIENT CAUSED THE TIP TO UNSCREW, IF THE DEVICE FAILED IN SOME WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YANKAUER SUCTION TUBE W/SCREW TIP INSTRUMENT KCB ALLEGIANCE HEALTHCARE CORP. AS165 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other