BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YANKAUER

    MDR report key: 445770 · Received February 25, 2003

    Report

    Report Number
    MW1027680
    Event Type
    Injury
    Date Received
    February 25, 2003
    Date of Event
    January 24, 2003
    Report Date
    February 25, 2003
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON TWO DATES IN 2003, THE PTS BIT OFF A PIECE OF THE YANKAUER SUCTION CATHETER WHILE IN THE PACU. THE FIRST PT REQUIRED AN EGD TO RETRIEVE THE BROKEN PIECE. POR THE SECOND PT THE PIECE WAS LOCATED IN THE SUCTION CANNISTER, HOWEVER THE PHYSICIAN ORDERED AN EGD BE PERFORMED TO BE CERTAIN THAT ALL WAS RETRIEVED. AN INVOLVED GROUP OF STAFF INVESTIGATED THE PRODUCT AND DISCOVERED THAT THE CATHETER WOULD BREAK OFF WHEN ONLY A LIGHT AMOUNT OF BITING PRESSURE WAS APPLIED. THE FACILITY HAS TAKEN THE PRODUCT OUT OF SERVICE AND REPORTED THE OCCURRENCE TO THE COMPANY'S REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YANKAUER SUCTION CATHETER JOL CARDINAL HEALTH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention