BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN-CPK-NG TUBE

    MDR report key: 8348922 · Received February 18, 2019

    Report

    Report Number
    9611594-2019-00028
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Report Date
    January 31, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(6) 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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 · 1

    IT WAS REPORTED AN ADVERSE EVENT INVOLVING A PATIENT USING A CORFLO NASOGASTRIC TUBE WAS FOUND ON THE MEDICAL ERROR DATABASE OF (B)(6). THE ADVERSE EVENT STATED: A NASOGASTRIC (NG) TUBE WAS INSERTED INTO A PATIENT¿S RIGHT BRONCHUS AND THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PATIENT WAS FEMALE IN HER 70¿S. SHE HAD DISTURBANCE OF CONSCIOUSNESS DUE TO ACUTE SUBDURAL HEMATOMA. A NEUROSURGEON DECIDED TO USE A NG TUBE FOR MEDICATION AND FEEDING. A NURSE CHANGED HER POSITION TO SEMI-FOWLER¿S POSITION. THE NEUROSURGEON BEGAN TO INSERT THE NG TUBE WITH THE PATIENT¿S HEAD BENDING FORWARD. THERE WAS NO COUGH REFLEX NOR RESISTANCE DURING THE INSERTION. AFTER THE INSERTION, GASTRIC SUCTION WAS PERFORMED FOR CONFIRMATION, BUT NO CONTENTS WERE OBTAINED. THEN, AUSCULTATION WAS PERFORMED. THE NEUROSURGEON HEARD WATER BABBLING SOUND, SO HE THOUGHT THE NG TUBE WAS INSERTED PROPERLY AND REMOVED THE GUIDEWIRE. AFTER REMOVING THE GUIDEWIRE, THE PATIENT WAS SENT TO THE X-RAY ROOM FOR RADIOGRAPHIC CONFIRMATION. A RADIOLOGIST FOUND THE NG TUBE WAS IN DIFFERENT PLACE THAN USUAL. THE NEUROSURGEON RECOGNIZED THE NG TUBE WAS INSERTED INTO RIGHT BRONCHUS AND THE WATER BABBLING SOUND HE HEARD IN AUSCULTATION WAS DUE TO PLEURAL FLUID. THE PATIENT WAS TREATED FOR PNEUMOTHORAX. THE NEUROSURGEON HAD MANY EXPERIENCES OF NG TUBE INSERTION AND HE DID NOT DO OR FEEL SOMETHING DIFFERENT FROM USUAL INSERTION PROCEDURE. THE HOSPITAL REVIEWED THIS EVENT AND CONCLUDED THAT THERE WAS NO NG TUBE INSERTION PROCEDURE FOR PATIENTS WITH HIGH RISK OF MISINSERTION. THE HOSPITAL REVISED THE PROCEDURE THAT AN NG TUBE INSERTION FOR PATIENTS WITH HIGH RISK OF MISINSERTION WOULD BE PERFORMED UNDER FLUOROSCOPIC GUIDANCE. THE EVENT DATE WAS NOT AVAILABLE, BUT IT MAY BE SOMETIME BETWEEN (B)(6) 2018 THROUGH (B)(6) 2018 ACCORDING TO THE ENTRY ON THE DATABASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141887 UNKNOWN-CPK-NG TUBE DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN-UN-CPK-NG TUBE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention