BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE W/ STYLET W/ ENFIT CONNECTOR

    MDR report key: 19020797 · Received April 2, 2024

    Report

    Report Number
    9611594-2024-00046
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    January 26, 2024
    Report Date
    January 3, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460468
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 02 APR 2024 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.

    Additional Manufacturer Narrative · 0

    UDI-PI IS UNAVAILABLE AS A LOT NUMBER WAS NOT PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 03 JAN 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 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

    IT WAS REPORTED VIA MEDWATCH UF REPORT (B)(4), ¿THE HOSPITAL RECENTLY BEGAN USING AVANOS NASOGASTRIC FEEDING TUBE WITH ENFIT CONNECTOR. THIS BRAND OF DOBHOFF TUBE IS A NEWER PRODUCT FOR US. THE DESIGN OF THIS PRODUCT INCLUDES TWO LUMENS, THEREFORE ALLOWING TUBE FEEDS TO BE ADMINISTERED WITH THE GUIDEWIRE IN PLACE. THE PREVIOUS NASOGASTRIC TUBE USED BY THE HOSPITAL HAD A SINGLE LUMEN, AND THEREFORE IT WAS NOT POSSIBLE TO ADMINISTER TUBE FEEDS WITH THE GUIDEWIRE IN PLACE. THE HOSPITAL HAS HAD SOME ADVERSE AND NEAR-MISS EVENTS INVOLVING WHERE TUBE FEEDS WERE ADMINISTERED OR NEARLY ADMINISTERED WITH THE GUIDEWIRE STILL IN PLACE. WE HAVE COMMUNICATED WITH THE MANUFACTURER REGARDING THIS ISSUE. WE SUGGESTED THE PRODUCT INCLUDE A VISUAL CUE ON THE OUTSIDE OF THE TUBING TO INDICATE THAT THE GUIDEWIRE IS IN PLACE. WE ALSO RECOMMENDED THAT THE MANUFACTURER ADD A VISUAL CUE ON THE PROXIMAL END OF THE GUIDEWIRE TO STATE ¿REMOVE BEFORE FEEDING.¿¿ PER ADDITIONAL INFORMATION RECEIVED ON 22-MAR-2024, ¿THE REPORT WAS INTENDED TO ALERT YOU TO WHAT WE BELIEVE TO BE A PRODUCT DESIGN DEFECT. BECAUSE THE SIDE PORT CAN BE USED FOR FEEDS, IT HAS CREATED A FALSE SENSE OF READINESS TO USE IF THE NURSE IS NOT FULLY AWARE THAT THE GUIDEWIRE IS STILL PRESENT.¿ THIS IS A NEW PRODUCT FOR THE FACILITY. ¿OUR PREVIOUS NASOGASTRIC TUBE DID NOT ALLOW TUBE FEEDS TO BE ADMINISTERED WITH THE GUIDEWIRE IN PLACE. IT WAS NOT KNOWN TO ALL THAT TUBE FEEDS CAN BE ADMINISTERED WITH THE GUIDEWIRE IN PLACE IN A SEPARATE LUMEN IN THIS PRODUCT. WHILE WE HAVE TRIED WIDESPREAD COMMUNICATION AND EDUCATION, ULTIMATELY WE THINK THIS IS A DESIGN FLAW.¿ ONE PATIENT WAS HARMED ¿ TUBE FEEDS INITIATED WITH GUIDEWIRE STILL IN PLACE. OTHER PATIENTS HAVE BEEN ¿NEAR MISSES¿, BUT THE ISSUE WAS IDENTIFIED BEFORE TUBE FEEDS INITIATED.¿ PER ADDITIONAL INFORMATION RECEIVED ON 26-MAR-2024, ¿FOR ONE PATIENT, TUBE FEEDS WERE INITIATED WITH THE GUIDEWIRE STILL IN PLACE. ONCE IDENTIFIED, THE GUIDEWIRE WAS REMOVED WITHOUT INCIDENT/ HARM.¿ NO INJURY OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567827 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE W/ STYLET W/ ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9431 UNKNOWN 00350770460468

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other