BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN, DH CPK NG TUBES

    MDR report key: 16414218 · Received February 21, 2023

    Report

    Report Number
    9611594-2023-00030
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Report Date
    February 21, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 21 FEB 2023 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 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE NURSE REPORTED, WHEN THEY WENT TO DE-CLOG THE TUBE IT HAD BALLOONED OUT ¿LIKE AN ANEURYSM¿ BELOW THE PATIENT¿S NOSE; THE DECISION WAS MADE TO REMOVE THE TUBE AND IT WAS DISCOVERED TO BE SEVERED. THE PREVIOUS DAY AN ATTEMPT WAS MADE TO DE-CLOG THE TUBE, WHICH HAD BEEN IN PLACE FOR ¿ABOUT¿ A MONTH. IT WAS ADDITIONALLY REPORTED AND THAT AN X-RAY (PERFORMED FOR ANOTHER REASON, SEVERAL DAYS PRIOR) REVEALED THE TUBE WAS ALREADY SEVERED; IT APPEARED TO HAVE SEVERED AROUND FOUR DAYS PRIOR TO REMOVAL. THERE WAS NO INJURY REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572660 UNKNOWN, DH CPK NG TUBES DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female