BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORGRIP SR NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM

    MDR report key: 24562350 · Received March 10, 2026

    Report

    Report Number
    9611594-2026-00119
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Report Date
    May 18, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770005904
    PMA / PMN Number
    K241185
    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 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. ALL INFORMATION REASONABLY KNOWN AS OF 09 MAR 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

    A NURSE AT (B)(6) HOSPITAL REPORTED THAT THE CORGRIP TUBE RETENTION SYSTEM WAS STRETCHING, CAUSING THE NASOGASTRIC TUBE TO BOW UPWARD, CREATING A POTENTIAL ASPIRATION RISK. SALES REPRESENTATIVE PROVIDED ADDITIONAL TRAINING AND EDUCATION ON DEVICE PLACEMENT AND USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504419 CORGRIP SR NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM DH CPK CORGRIP TUBE RETENTION KNT AVANOS MEDICAL INC. 26-010 UNKNOWN 00350770005904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown