BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE

    MDR report key: 20075023 · Received August 27, 2024

    Report

    Report Number
    9611594-2024-00177
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 26, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460925
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 26 AUG 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, NASOGASTRIC (NG) TUBE BROKE WHILE USED ON A PATIENT. PATIENT STARTED COUGHING AND RETCHING. THE LENGTH OF THE TUBE CHANGED BY 15CM. PER ADDITIONAL INFORMATION RECEIVED ON 12AUG2024, THE PATIENT IS IMPROVING ON WARD. THERE WAS NO IMPACT FROM THE NG TUBE THAT REMAINED INSIDE THE ESOPHAGUS. IT WAS REVIEWED BY THE GASTROENTEROLOGIST AND THE PLAN IS TO WAIT FOR TUBE TO PASS NATURALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17575 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE DH CPK NG TUBES KNT AVANOS MEDICAL INC. 42-9368 UNKNOWN 00350770460925

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female