BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFIT PVC FEEDING TUBE ORANGE 8FR 40CM

    MDR report key: 20521890 · Received October 24, 2024

    Report

    Report Number
    3011270181-2024-00111
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Report Date
    January 24, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770000923
    PMA / PMN Number
    K120182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 24-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 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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 23-OCT-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 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 VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT MW (B)(4) THE FOLLOWING INFORMATION: BABY HAD NUMEROUS APNEA AND BRADYCARDIC EPISODES. NOTED THAT ORAL GASTRIC TUBE WAS STIFF AND COULD POSSIBLY BE CAUSING VAGAL EPISODES. ALSO, SEVERAL, SMALL EMESIS EPISODES. THE OG [ORAL GASTRIC] TUBE REMOVED AND IT WAS NOTED TO BE VERY CURLED/MISSHAPED AND STIFF. THE TUBE HAD BEEN IN PLACE LESS THAN 2 WEEKS. IT WAS REPLACED WITH A NEW 5 FR TUBE THAT IS MORE PLIABLE. NO MORE EPISODES FOR THE REST OF THE SHIFT. THIS BABY IS A LITTLE OVER 1 KG AND WAS NOT TOLERATING THE 8 FR TUBE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: TO VENT THE STOMACH FOR DECOMPRESSION AND ASPIRATE THE AIR OFF AT CARE TIMES. OTHER THERAPIES USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: CPAP [(CONTINUOUS POSITIVE AIRWAY PRESSURE)] FOR RESPIRATORY DISTRESS SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714192 ENFIT PVC FEEDING TUBE ORANGE 8FR 40CM DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) KNT AVANOS MEDICAL INC. FTS8.0V-NC TY221212 00350770000923

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male CPAP MACHINE