BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES

    MDR report key: 21791900 · Received April 7, 2025

    Report

    Report Number
    9611594-2025-00076
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 7, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    117

    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. THE ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 07 APR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, ¿NP [NURSE PRACTIONER] ON NUTRITION SUPPORT TEAM REPORTS 140CM, 8FR CORFLO TUBE BURST WHEN IN PATIENT. TUBE WAS INITIALLY PLACED UNDER FLUOROSCOPY, PATIENT DISCHARGED TO LTC [LONG TERM CARE], RETURNED TO HOSPITAL SOLELY FOR CLOGGED TUBE. NP TRIED TO UNCLOG WITH 60CC SYRINGE AND WARM WATER WITH NO LUCK. SHE REMOVED THE TUBE AND DID NOT REALIZE IT WAS BURST. SHE PLACED A CORTRAK TUBE WITH SOME TROUBLESHOOTING NEEDED. UPON X-RAY, IT WAS SEEN THERE WERE 2 TUBES - THE CORTRAK AND THE BURST CORFLO TUBE. PATIENT NEEDED REMAINING PORTION ON CORFLO REMOVED BY ENDOSCOPY. NO SIGNIFICANT HARM NOTED TO PATIENT, PATIENT DISCHARGED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943201 UNKNOWN CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female