BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 9357583 · Received November 21, 2019

    Report

    Report Number
    3011270181-2019-00068
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    October 18, 2019
    Report Date
    February 28, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10680651472011
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0203018739, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 28-FEB-2020 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.

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. 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. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE FEEDING TUBE PERFORATED THE PATIENT¿S HIATAL HERNIA DURING INSERTION ON (B)(6) 2019. IT WAS IDENTIFIED TWO DAYS LATER, ON (B)(6) 2019, WHEN THE PATIENT¿S STOMACH WAS DISTENDED AND A COMPUTED TOMOGRAPHY CT SCAN WAS ORDERED. THE PATIENT REQUIRED EMERGENT SURGICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 30-OCT-2019 STATED THE NURSE FREQUENTLY DID CORTRAK RETRACING'S AND ALSO FORGOT TO SELECT "END" BEFORE PULLING THE STYLET OUT. THE RISK MANAGEMENT PERSONNEL DID NOT BLAME THE CLINICIAN OR THE CORTRAK DEVICE FOR THE COMPLICATION. THEY DON¿T KNOW WHEN THE PERFORATION OCCURRED AND IT MAY HAVE BEEN FROM OTHER PROCEDURES. RADIOLOGY ALSO READ THE RADIOLOGY EXAM RESULTS NOTING THE TIP WAS IN THE INCORRECT POSITION. ADDITIONAL INFORMATION RECEIVED 01-NOV-2019 STATING THE PATIENT WAS "STABLE BUT VERY ILL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152051 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 0203018739 10680651472011

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention