BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CORPAK NASOGASTRIC TUBE

    MDR report key: 8426851 · Received March 16, 2019

    Report

    Report Number
    9611594-2019-00053
    Event Type
    Injury
    Date Received
    March 16, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 5, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 15 MAR 2019 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FINE BORE NASOGASTRIC (NG) TUBE WAS MISPLACED INTO THE RIGHT LUNG, CONFIRMED BY CHEST X-RAY. THE PATIENT HAD A LARGE PNEUMOTHORAX ON THE RIGHT SIDE, AND A RAPIDLY INCREASING OXYGEN REQUIREMENT. DUE TO INCREASING RESPIRATORY DISTRESS, THE PATIENT HAD A NEED DECOMPRESSION OF THE RIGHT CHEST, FOLLOWED BY THE INSERTION OF A RIGHT SIDE CHEST DRAIN. THIS WAS FOLLOWED UP BY RADIOGRAPHIC IMAGING. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219936 UNKNOWN CORPAK NASOGASTRIC TUBE CPK ENTERAL FEEDING KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention