BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK2 NG/NI FEED TUBE, ELECTROMAGNETIC TRANSMIT STYLET, ENFIT

    MDR report key: 22081886 · Received May 23, 2025

    Report

    Report Number
    9611594-2025-00109
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Report Date
    September 19, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460536
    PMA / PMN Number
    K220588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    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 21-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 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

    ONE PARTIAL FEEDING TUBE WAS RECEIVED AND EVALUATED. THE PROXIMAL PORTION, WITH THE CONNECTED PORTS WAS NOT RETURNED. THE SAMPLE WAS THE DISTAL PORTION, INCLUDED THE BOLUS TIP. THE OVERALL LENGTH MEASURES APPROXIMATELY 43CM FROM THE BOLUS TIP. THERE WAS BALLOONING AT THE PROXIMAL END, WHERE THE BREAK OCCURRED. THE TUBING EXHIBITED DISCOLORATION. PER OBSERVATIONS DOCUMENTED ABOVE, DRIED MATTER WAS FLUSHED FROM THE TUBE DURING THE DECONTAMINATION PROCESS. THE ENDS OF THE TUBE WERE EXAMINED UNDER MAGNIFICATION. THERE WAS NO VISIBLE OCCLUSION AT THE BALLOONED/RUPTURED END OR IN THE BOLUS TIP. USING A SYRINGE FITTED WITH A DISPENSER TIP, WATER WAS FLUSHED THROUGH, FROM THE RUPTURED END. THE WATER FLOWED WITHOUT RESISTANCE AND EXITED THE BOLUS TIP. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 19-SEP-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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CORTRAK NASOGASTRIC (NG) TUBE WAS ORIGINALLY PLACED (B)(6) 2025 WITHOUT ANY DIFFICULTY...THAT TUBE HAS NOW "POPPED IN TWO SEPARATE AREAS," EXTERNALLY AND INTERNALLY. THE USER WAS UNABLE TO STATE WHERE TUBE WAS RUPTURED FOR INTERNAL RUPTURE BUT STATES EXTERNAL WAS "BETWEEN THE NARES AND THE PORTS." A GASTROINTESTINAL (GI) PROCEDURE WAS PERFORMED (B)(6) 2025 TO REMOVE INTERNAL PORTION OF TUBE. THE TUBE RUPTURED INTERNALLY "AS EARLY AS THE 26TH" BECAUSE IT WAS VISUALIZED ON X RAY; EXTERNAL RUPTURE FOUND 2-DAYS AGO. THE PATIENT WAS ON CONTINUOUS FEEDS; UNSURE OF WHAT TYPE OF MEDICATIONS WERE BEING GIVEN. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 16-MAY-2025 STATING THE PATIENT'S FEEDING SOLUTION WAS NEPRO WITH CARB STEADY. THE DEVICE WAS USED FOR TUBE FEEDING AND FLUSHES ONLY. MEDICATIONS WERE SWALLOWED. THE PATIENT WAS ON ORAL AND TUBE FEEDING DIET. THE TUBE WAS ROUTINELY FLUSHED WITH MEDICATION EVERY 4-HOURS WITH ASSESSMENTS AND AS NEEDED. A 35 ML SYRINGE WAS USED TO TRY AND FLUSH THE INITIAL CLOG; A 12 ML SYRINGE WAS USED WHEN UNABLE TO GAIN PATENCY. IT WAS UNKNOWN IF THERE WAS CLOGGING PRIOR TO THE TUBE RUPTURE. WHEN FLUSHING THE DEVICE TYPICALLY IT WAS MANUALLY FLUSHED. SOMETIMES THE REGISTERED NURSE [RN] WOULD PROGRAM A FLUSH FROM THE PUMP WHEN A FREE WATER FLUSH IS ORDERED. STERILE WATER WAS USED TO UNCLOG THE TUBE. THERE WAS NO REPORTED INJURY, BUT THE PATIENT HAD AN UNPLANNED PROCEDURE, ACBEDSIDE SCOPE. THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728481 CORTRAK2 NG/NI FEED TUBE, ELECTROMAGNETIC TRANSMIT STYLET, ENFIT DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9551TRAK2 UNKOWN 00350770460536

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female