BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YANKAUER,BULB TIP,W/O VENT,RIGID,STERILE

    MDR report key: 16435066 · Received February 24, 2023

    Report

    Report Number
    16435066
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    February 13, 2023
    Report Date
    February 13, 2023
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WE HAVE BEEN EXPERIENCING LOW SUCTION WITH SOME PROCEDURES. AFTER LOOKING CLOSELY AT THE YANKAUER SUCTION TIPS WE NOTICED THERE IS A HOLE IN THE HANDLE THAT IS NOT SUPPOSED TO BE THERE. WE ALERTED STAFF AND REMOVED THE FEW WE FOUND. WE PULLED PRODUCT WITH THE SAME LOT NUMBERS---ONLY A FEW HAD THE HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022809 YANKAUER,BULB TIP,W/O VENT,RIGID,STERILE CATHETER AND TIP, SUCTION JOL MEDLINE INDUSTRIES DYND50130 48622090001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown