BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORGRIP SR NG/NI FEEDING TUBE RETENTION SYSTEM

    MDR report key: 24912562 · Received April 17, 2026

    Report

    Report Number
    9611594-2026-00199
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Report Date
    April 20, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770005904
    PMA / PMN Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: COMPONENT CODES/COMPONENT CODES/4756 - APPROPRIATE TERM/CODE NOT AVAILABLE: MONOFILAMENT. THE ACTUAL DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. 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 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 "THERE WAS A BROKEN CORGRIP ON A PATIENT." A NASAL BRIDLE THAT BROKE SPONTANEOUSLY ¿ OF NOTE, THIS OCCURRED WHILE A PATIENT WAS PRONE UNABLE TO FLUSH TUBE WHILE CLIP WAS IN PLACE." PATIENT WAS BRIDLE WHILE IN THE SUPINE POSITION. BRIDLE WAS WORKING AS DESIGNED FOR A FEW HOURS. STAFF HAD TO MOVE THE PATIENT TO A SUPINE POSITION. AFTER A COUPLE HOURS, THE NURSE NOTICED THE BRIDLE SNAPPED AND TUBE CAME OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968131 CORGRIP SR NG/NI 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 Female