BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN NASOGASTRIC FEEDING TUBE

    MDR report key: 19354142 · Received May 20, 2024

    Report

    Report Number
    9611594-2024-00085
    Event Type
    Death
    Date Received
    May 20, 2024
    Date of Event
    July 1, 2023
    Report Date
    December 3, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H10. LINK TO MAUDE ADVERSE EVENT REPORT: HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFMAUDE/DETAIL.CFM?MDRFOI__ID=17641489&PC=KNT&DEVICE_SEQUENCE_NO=1. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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

    IT'S BEEN DETERMINED THAT THE PRODUCT INVOLVED IN THIS INCIDENT IS NOT AN AVANOS PRODUCT. THE MODEL NUMBER AND LOT NUMBER REPORTED ON FDA MAUDE REPORT NUMBER (B)(4) DOES NOT BELONG TO AVANOS. NO FURTHER INFORMATION WILL BE SUBMITTED REGARDING 9611594-2024-00085. ALL INFORMATION REASONABLY KNOWN AS OF 03 DEC 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

    H6: HEALTH EFFECT - IMPACT CODE: 4650 APPROPRIATE TERM/CODE NOT AVAILABLE: CARDIAC ARREST. 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 20 MAY 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA FDA MAUDE REPORT NUMBER (B)(4), ¿ON THE MORNING ON JULY 1ST, TWO ATTEMPTS TO PLACE A CORPAK WERE MADE. BOTH ATTEMPTS ENDED UP IN THE LUNGS. THE SICU FELLOW USED A NG [NASOGASTRIC] TUBE FOR THE 3RD ATTEMPT, AND WAS ABLE TO PLACE THE TUBE IN THE GASTRIC BODY. A COUPLE HOURS LATER THE PATIENT EXPERIENCED CARDIAC ARREST. AND CODE BLUE RESPONSE INITIATED. PATIENT WAS FOUND TO HAVE A PNEUMOTHORAX. PRESUMPTIVELY CAUSED BY THE FAILED CORPAK PLACEMENTS. FAMILY DECIDED TO PURSUE COMFORT MEASURES, AND PATIENT PASSED ON THE 3RD.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609467 UNKNOWN NASOGASTRIC FEEDING TUBE DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Life Threatening| D