BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 21970584 · Received May 6, 2025

    Report

    Report Number
    9611594-2025-00088
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    March 25, 2025
    Report Date
    July 2, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460321
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 05 MAY 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 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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THERE WAS A DAMAGE IDENTIFIED APPROXIMATELY BETWEEN 36 CM AND 37 CM. THE BLACK DISCOLORATION WAS SEEN AT THE ENTIRETY OF THE TUBE IN DIFFERENT LOCATIONS TOWARDS THE BOLUS TIP (DISTAL END) OF THE TUBE. AT THE 36-37 CM MARKED LOCATION, THE TUBING APPEARED TO HAVE EXPANDED TO FORM A BALLOON SHAPE. DURING CUTTING OF TUBE TO EXPOSE THE CLOGGING/BLOCKING ACTIVITY IN THE TUBE, BROWNISH CREAMY MATERIAL MIXED WITH HARDENED MATERIALS STUCK IN THE TUBE WERE EXHIBITED. THE MATERIAL RESIDUE WAS CLEANED, FLUSHED THROUGH WITH WATER. THE TUBING WAS INSPECTED AND DID NOT SEE ANY EXCESS EMBEDDED MATERIAL OTHER THAN THE HARDENED BUILD-UPS. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 02 JUL 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 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 21 CFR 803, 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, ¿PROBE INSTALLED ON (B)(6) 2025. THE PATIENT COMPLAINS OF SIGNIFICANT DISCOMFORT. DIFFICULTY REMOVING CATHETER ON (B)(6) 2025. PRESENCE OF AN INCOMPRESSIBLE HERNIA APPROXIMATELY 2CM IN DIAMETER AT THE 36CM MARK ON THE PROBE. CONSEQUENCES FOR THE PATIENT: SIGNIFICANT DISCOMFORT WITH THE PROBE, DIFFICULTY SWALLOWING AND BREATHING. CHANGE OF DEVICE.¿ PER ADDITIONAL INFORMATION RECEIVED ON 15APR2025, THE HERNIA IS REFERENCING A PORTION OF THE NASOGASTRIC TUBE THAT BALLOONED. THE TUBE WAS REMOVED WITH DIFFICULTY BUT WITHOUT SURGERY. THE PATIENT IS BETTER NOW THAT A NEW TUBE IS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67718 CORFLO NG/NI FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-7431 UNKNOWN 00350770460321

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female