BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM - RECEIVER UNIT

    MDR report key: 8887369 · Received August 13, 2019

    Report

    Report Number
    3006646024-2019-00012
    Event Type
    Injury
    Date Received
    August 13, 2019
    Report Date
    August 13, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10680651472127
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 07 AUG 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE RIGHT LUNG DURING A NASOGASTRIC (NG) TUBE PLACEMENT USING THE COR TRAK 2. THE PATIENT IS OK BUT REQUIRED VENTILATION AT THE TIME OF THE INCIDENT. THE ISSUE WAS REPORTED TO BE CAUSED BY "USER ERROR." PER ADDITIONAL INFORMATION RECEIVED ON 7 AUG 2019, THE PATIENT WAS NOT HARMED, BUT A CHEST TUBE WAS PLACED. THE PATIENT IS CURRENTLY DOING FINE. IT WAS AGAIN REPORTED THAT THE CAUSE OF THE ISSUE WAS "USER ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684673 CORTRAK ENTERAL ACCESS SYSTEM - RECEIVER UNIT DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0952 UNKNOWN 10680651472127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention