BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS

    MDR report key: 20705566 · Received November 18, 2024

    Report

    Report Number
    20705566
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    August 20, 2024
    Report Date
    August 20, 2024
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    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

    EVENT REPORTED TO RN COORDINATOR BY DR. AS DISCUSSED, I HAVE PLACED TWO PEG TUBES ON MY CALL WEEK. BOTH PROCEDURES HAD AN ESOPHAGEAL SUPERFICIAL TEAR VISUALIZED AFTER PULLING THE PEG TUBE OVER THE GUIDEWIRE. FMF AVANOS REF#8180-20, LOT#30297186. IN BOTH INSTANCES, I HAD TO PLACE A CLIP TO CLOSE THE MUCOSAL TEAR. PLEASE SEE IF THESE PEG TUBE LOT CAN BE INVESTIGATED OR ALTERNATIVELY SWITCHED TO A DIFFERENT BRAND. I HAVE NEVER HAD AN ISSUE IN THE PAST. MY FEELING IS THAT THE BUMPER OR PLASTIC CATHETER IS TOO SHARP OR STIFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619911 AVANOS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. 30297186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown