BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE

    MDR report key: 14403152 · Received May 14, 2022

    Report

    Report Number
    9611594-2022-00065
    Event Type
    Malfunction
    Date Received
    May 14, 2022
    Date of Event
    February 15, 2022
    Report Date
    June 13, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770456805
    PMA / PMN Number
    K831328
    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. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 12 MAY 2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS 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).

    Additional Manufacturer Narrative · 0

    BASED ON THE PICTURES RECEIVED, THIS IS NOT AN AVANOS PRODUCT. THE DEVICE WAS NOTED AS AN AMT DEVICE. NO ADDITIONAL INFORMATION WILL BE PROVIDED AND SUBMITTED FOR AVANOS REPORT NUMBER 9611594-2022-00065. ALL INFORMATION REASONABLY KNOWN AS OF 13-JUN-2022 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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS 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 THAT THE NASOGASTRIC (NG) TUBE HAD PARTIALLY MIGRATED OUT OF THE PATIENT THE MARKER AT THE PATIENT'S LIPS WAS NOTED TO BE 40CM, AND AT THE PREVIOUS CHECK IT HAD BEEN AT 53CM. THE FEED WAS STOPPED AND A CHEST X RAY WAS PERFORMED. THE ATTENDING DOCTOR DETERMINED VIA THE X RAY THAT THE NG FEEDING TUBE WAS NOT SAFE TO USE IN THE CURRENT POSITION. THE NG TUBE WAS ADVANCED TO 55CM AT THE LIPS AND DETERMINED TO BE SAFE TO USE. PER ADDITIONAL INFORMATION RECEIVED 4 MAY 2022, THERE WAS NO INJURY TO THE PATIENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395689 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE DH CPK NG TUBES KNT AVANOS MEDICAL INC. 20-1155 UNKNOWN 00350770456805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown