BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 NASOGASTRIC / NASOINTESTINAL FEEDING TUBES

    MDR report key: 24903968 · Received April 16, 2026

    Report

    Report Number
    9611594-2026-00228
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Report Date
    April 16, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460536
    PMA / PMN Number
    K220588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS INITIALLY DEEMED NOT REPORTABLE BASED ON OUR REPORTING STRATEGY ACTIVE AT THE TIME OF THE ALERT DATE; HOWEVER, FOLLOWING A RECENT RETROSPECTIVE REVIEW OF COMPLAINTS THIS EVENT WAS MADE REPORTABLE OUT OF AN ABUNDANCE OF CAUTION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE RETURNED SAMPLE EXHIBITED TUBING DAMAGE AND DISCOLORATION. A RUPTURE WAS IDENTIFIED APPROXIMATELY AT THE 42 CM MARKING WHERE THE TUBING EXPANDED AND SPLIT, FORMING AN OPENING. INSPECTION NOTED RESIDUE AND DISCOLORATION ALONG THE TUBING, WITH NO EVIDENCE OF EMBEDDED MANUFACTURING DEFECTS. ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED FAILURE WAS CONFIRMED DURING SAMPLE EVALUATION; HOWEVER, NO MANUFACTURING NONCONFORMANCES OR PROCESS DEVIATIONS WERE IDENTIFIED. THE OBSERVED TUBING EXPANSION AND RUPTURE ARE CONSISTENT WITH USE-RELATED FACTORS. THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. ALL INFORMATION REASONABLY KNOWN AS OF 16 APR 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 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

    THE CUSTOMER REPORTED THAT ONE CORTRAK FEEDING TUBE WAS FOUND TO HAVE A ¿PINHOLE PERFORATION.¿ THE DEVICE WAS PROVIDED TO THE FACILITY WITHOUT ADDITIONAL DETAILS REGARDING THE EVENT CIRCUMSTANCES. NO PATIENT OUTCOME OR INJURY INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957737 CORTRAK 2 NASOGASTRIC / NASOINTESTINAL FEEDING TUBES DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9551TRAK2 UNKNOWN 00350770460536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown