BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE YANKAUER SUCTION BULB

    MDR report key: 15470161 · Received September 23, 2022

    Report

    Report Number
    15470161
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 8, 2022
    Report Date
    September 13, 2022
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE, TWO YANKAUERS FROM THE SAME LOT BROKE DURING THE CASE WHILE USING SURGEON WAS USING SUCTION AND PUSHING DOWN ON THE DEVICE. THE PIECES OF THE YANKAUERS AND PACKAGING WERE COLLECTED BY STAFF. THERE WAS NO KNOWN PATIENT INJURY. REF: YANK1002, LOT: 2112KN02A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534113 MEDICHOICE YANKAUER SUCTION BULB CATHETER AND TIP, SUCTION JOL OWENS & MINOR DISTRIBUTION, INC. YANK1002 2112KNO2A

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA Male