BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC STANDARD PEG KIT - PULL METHOD

    MDR report key: 20969357 · Received December 18, 2024

    Report

    Report Number
    3006646024-2024-00034
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 19, 2024
    Report Date
    December 18, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K924065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR LOT 30290837 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 17 DEC 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, ¿OUR PHDS FIND THAT THE MIC PEG SET IS MUCH HARDER TO PULL OUT FOR SWITCHING TO A MIC-KEY BUTTON. THEY HAVE TO PULL VERY HARD AND NOW AGAIN YOU HAVE TO DO A GASTROSCOPY EXAMINATION TO PULL OUT THE MIC PEG AS IT IS SO STIFF AND HARD. THE NEGATIVE IS THAT THE PATIENT HAS TO DO A NEW GASTROSCOPY WHERE WE GIVE THE PATIENT SEDATIVE MEDICATION TO CUT THE PEG AND REMOVE THE PLATE WITH THE GASTROSCOPE, WHICH WAS NOT PLANNED FROM THE BEGINNING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988044 MIC STANDARD PEG KIT - PULL METHOD DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 9640-20 30290837

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male