BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET

    MDR report key: 25300338 · Received May 27, 2026

    Report

    Report Number
    9611594-2026-00366
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    September 18, 2023
    Report Date
    May 27, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770457991
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    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. THE DEVICE HISTORY RECORD REVIEW FOR LOT 30133122 CONFIRMED THE PRODUCT WAS MANUFACTURED ACCORDING TO APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS, WITH NO NONCONFORMANCES, CAPAS, ABNORMAL CONDITIONS, OR PROCESS DEVIATIONS IDENTIFIED. NO SAMPLE WAS RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 26 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 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00366 FOR THE FIRST REPORT. REFER TO 9611594-2026-00367 FOR THE SECOND REPORT. THE CUSTOMER REPORTED THAT A CORFLO NASOGASTRIC TUBE BURST DURING USE IN THE ICU. THE TUBE REPORTEDLY BURST AFTER APPROXIMATELY ONE DAY OF USE. NO PATIENT INJURY OR MEDICAL TREATMENT WAS REPORTED; HOWEVER, THE TUBE WAS REPLACED WITH A NEW TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475970 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET DH CPK NG TUBES KNT AVANOS MEDICAL INC. 20-9432 30133122 00350770457991

    Patients

    Seq Age Sex Outcome Treatment
    1