BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NASOGASTRIC TUBE

    MDR report key: 7737037 · Received July 31, 2018

    Report

    Report Number
    9611594-2018-00099
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    July 2, 2018
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 17 JUL 2018 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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NASOGASTRIC (NG) TUBE WAS INSERTED IN ORDER TO GIVE MEDICATIONS AND FEED. HOSPITAL STAFF WAS UNABLE TO OBTAIN PH, AND AN X-RAY CONFIRMED NG TUBE HAD BEEN PLACED IN RIGHT MAIN BRONCHUS. THE NG TUBE WAS REMOVED AND THE PATIENT'S CONDITION DETERIORATED. A SECOND CHEST X-RAY CONFIRMED RIGHT SIDE PNEUMOTHORAX AND EFFUSION. A CHEST DRAIN WAS INSERTED AND THE PATIENT WAS MOVED TO GENERAL INTENSIVE CARE UNIT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577201 UNKNOWN NASOGASTRIC TUBE DH CPK NG TUBES KNT AVANOS MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention