BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 21279442 · Received January 30, 2025

    Report

    Report Number
    9611594-2025-00011
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    December 21, 2024
    Report Date
    August 24, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460284
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS 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. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 30-JAN-2025 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, INC. 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.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION FINDINGS/INVESTIGATION CONCLUSIONS-APPROPRIATE TERM/CODE NOT AVAILABLE: INAPPROPRIATE USE. THE SUBJECT SAMPLE PROVIDED WAS EVALUATED CONFIRMING AT THE 49CM MARKED LOCATION, THE TUBING APPEARED TO HAVE EXPANDED TO FORM A BALLOON SHAPE WHICH BURST IN AXIALLY CAUSING AN OPENING TO THE TUBE. THE BOLUS END TIP WAS NOT RETURNED WITH THE ENTIRETY OF TUBING. BOTH BREAKING POINTS EXHIBITED UNKNOWN DRIED FOREIGN MATERIAL RESIDUE. THE ROOT CAUSE OF THE REPORTED ISSUE SEEMS TO BE A USER RELATED PROBLEM SINCE AS PER THE IFU (INSTRUCTION FOR USE), VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS, OR UNBLOCK THE TUBE. ALL INFORMATION REASONABLY KNOWN AS OF 22-AUG-2025 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, INC. COMPLAINT DATABASE AND IDENTIFIED AS (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 THE PATIENT'S NASO-JEJUNAL TUBE WAS LEAKING FEEDING SOLUTION OUT OF THE PATIENT'S NOSE. THE X-RAY CONFIRMED PLACEMENT WAS APPROPRIATE. THE TUBE WAS PULLED AND A BREAKDOWN AREA WAS NOTICED ON THE TUBE." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116023 CORFLO NG/NI FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-6438 UNKNOWN 00350770460284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown