BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR

    MDR report key: 25155015 · Received May 12, 2026

    Report

    Report Number
    9611594-2026-00309
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    July 30, 2025
    Report Date
    May 12, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460502
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30298711, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 12-MAY-2026 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 2282736 THE FOLLOWING INFORMATION: B [BACKGROUND]: HAS HAD MULTIPLE FEEDING TUBES WITH CLOGGING ISSUES. LAST TUBE PLACED IN IR [INTERVENTIONAL RADIOLOGY] ON [DATE REDACTED].ON [DATE REDACTED] - APPROXIMATELY 2.5 WEEKS AFTER LAST FEEDING LINE WAS PLACED, RN NOTED FEEDING PUMP ALARMING, UNABLE TO FLUSH ND [NASODUODENAL] TUBE, MD NOTIFIED. CONTRAST GIVEN AT BEDSIDE AND FOUND TUBE DISRUPTED WITH CONTRAST FILLING STOMACH, PROXIMAL PART OF TUBE IN STOMACH AND DISTAL PART OF TUBE IN DUODENUM. A: UNINTENTIONALLY RETAINED FOREIGN OBJECT. PER UNIT CNS [CLINICAL NURSE SPECIALIST], TUBE WAS MANAGED PER STANDARDS. WHEN MEDS ADMINISTERED, CRUSHED, DILUTED, FLUSHED APPROPRIATELY, USE OF "CLOG ZAPPER" WHEN NOTED TUBE FLUSHING SLUGGISHLY. OF NOTE PATIENT DOES NOT RECEIVE MANY MEDS THROUGH TUBE, LAST MED ADMINISTERED 3 HOURS PRIOR TO CLOGGING EPISODE. R: CONTINUE TO FOLLOW STANDARD CRUSHING, DILUTING, FLUSHING GUIDELINES WHEN ADMINISTERING MEDS. TO IR TOMORROW FOR REMOVAL OF RETAINED TUBE AND PLACEMENT OF ND TUBE. THE NGT [NASOGASTRIC TUBE] DEVICE BURST OPEN WHILE IN PLACE. PART OF THE NGT WAS RETAINED IN THE PATIENT'S STOMACH. VISCOUS FEEDS ARE LIKELY CLUMPING UP IN THE NGT. THE NGT BURST WHILE INSIDE THE PATIENT. THE TUBE WAS CLOGGED, AND THE BUILT-UP PRESSURE BURST THE TUBE. PATIENT HAS TO GO TO IR TO RECOVER THE RETAINED FOREIGN OBJECT. TUBE IS STILL IN PLACE; IR WILL REMOVE THE TUBE AND REPLACE WITH NEW TUBE FOR USE. NO REPORTER DETAILS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562508 CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9438 30298711 00350770460502

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Male