BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ENTERAL FEEDING TUBE

    MDR report key: 12956892 · Received December 7, 2021

    Report

    Report Number
    9611594-2021-00177
    Event Type
    Death
    Date Received
    December 7, 2021
    Date of Event
    October 5, 2021
    Report Date
    February 16, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 15-FEB-2022 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

    ALL INFORMATION REASONABLY KNOWN AS OF 16-FEB-2022 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 COMPLAINT PRODUCT WAS NOT 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 07-DEC-2021 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).

    Description of Event or Problem · 0

    FEEDING TUBE PLACED ON (B)(6) 2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ENTERAL FEEDING CHILD EXPIRED DUE TO ASPIRATION. THE FEEDING TUBE PLACED ON (B)(6) 2021 DUE TO A HEART CONDITION CAUSING THE PATIENT TO BREATHE "QUICKLY" AND EXPERIENCE DIFFICULTY DRINKING. EVERY TIME THE PATIENT TRIED TO TAKE A BOTTLE SHE WOULD CHOKE, "WHICH IS WHY A FEEDING TUBE WAS NEEDED." THE GASTROSTOMY TUBE (G-TUBE) WAS REPLACED ON (B)(6) 2021. THE PATIENT WAS ELEVATED OR IN A "SWING" DURING FEEDS. THE FEEDINGS WERE ADMINISTERED THROUGH A "JOEY PUMP" AND BELIEVES IT WAS A RATE OF 26ML/HR CONTINUOUS FEEDS. ON (B)(6) 2021 THE CAREGIVER NOTICED THE G-TUBE WAS LEAKING FROM THE STOMA SITE. THE CAREGIVER CALLED THE ON-CALL DOCTOR AND WAS TOLD TO PUT GAUZE UNDER THE FEEDING TUBE AND WAIT SINCE THE PATIENT HAD AN APPOINTMENT WITH HER CARDIOLOGIST IN THE MORNING WHERE HER GASTRO-INTESTINAL (GI) PHYSICIAN COULD CHECK. THE FEEDING TUBE WAS SECURED DOWN WITH TAPE. ON (B)(6) 2021 THE PATIENT'S MACHINE WENT OFF TO LET THE CAREGIVER KNOW THERE WAS NO HEARTBEAT AND THE PATIENT WAS NOT RESPONSIVE. THE CAREGIVER CALLED 911 STARTED CARDIO PULMONARY RESUSCITATION (CPR). DURING CPR FORMULA WAS COMING OUT OF THE PATIENT'S NOSE AND MOUTH. THE AMBULANCE ARRIVED AND THE PATIENT WAS TAKEN TO THE HOSPITAL. THE PATIENT PASSED AWAY ON (B)(6) 2021 CHILD PASSED ON AT 10:10 AM. (B)(6) OLD. CAUSE OF DEATH WAS NOTED AS CONGESTIVE HEART FAILURE. THE CARDIOLOGIST LOOKED AT X-RAYS TAKEN POST DEATH WHERE THE RIGHT LUNG WAS COLLAPSED AND THERE WAS FLUID IN THE LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854681 UNKNOWN ENTERAL FEEDING TUBE DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Female Death