BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 18673778 · Received February 8, 2024

    Report

    Report Number
    3011270181-2024-00014
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 8, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K220588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 08-FEB-2024 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). 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED "010924 PIR REPORTS, "WE HAD AN INCIDENT LAST WEEK/ A TUBE WAS PLACED AND CAUSED A PNEUMOTHORAX REQUIRING A CT (CHEST TUBE). WENT TO LOOK AT THE TRACINGS AND CAN'T MAKE ANY SENSE OF THEM. NOT SURE IF BAD TRANSMITTER PLACEMENT OR BAD TECHNIQUE. WHEN I CALLED TO LET HER KNOW I WOULD BE OVER TO DOWNLOAD THE IMAGES SHE REPLIED THEIR INTERNAL TEAM WAS REVIEWING AS THE LADY MAY HAVE HAD THE PNEUMO. THEY ASKED TO HOLD OFF ON REVIEWING THE TRACINGS. I ASKED IF THE PATIENT EXPIRED AND SHE REPLIED YES HE DID NOT KNOW BUT THE PATIENT WAS CHANGED TO COMFORT CARE WHICH WAS NEEDED DUE TO OVERALL PROGNOSIS NOT NECESSARILY RELATED TO THE INCIDENT. SHE ALSO REPORTED THE PATIENT HAD ALTERED ANATOMY AND POSSIBLY WAS VERY CONTRACTED. THE RN REPORTING THE INCIDENT DID NOT PLACE THE FEEDING TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60735 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 UNKNOWN 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other