BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 6644321 · Received June 15, 2017

    Report

    Report Number
    3009124963-2017-00029
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Report Date
    July 26, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    10815149024698
    PMA / PMN Number
    K113351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS RECEIVED IN USED CONDITION. NO PHYSICAL DAMAGE WAS NOTED TO THE MONITOR UNIT AND RECEIVER UNIT. THE RETURNED SYSTEM WAS EVALUATED AND TESTED WITH CONTROLLED STYLET AND INTERCONNECT CABLE RETURNED WITH THE SYSTEM. THE STYLET USED WHEN THE FAILURE MODE WAS OBSERVED WAS NOT RETURNED FOR EVALUATION. SYSTEM WAS EVALUATED AND ALL TESTED RESULTS WERE WITHIN SPECIFICATIONS. ROOT CAUSE COULD NOT BE IDENTIFIED. THE REPORTED COMPLAINT WAS NOT CONFIRMED. ALL INFORMATION REASONABLY KNOWN AS OF 14-AUG-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. HALYARD HEALTH 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).

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE SAMPLE EVALUATION AND INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 29-JUN-2017 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS IT IS UNKNOWN WHICH LOT IS ASSOCIATED WITH THE EVENT. ALL INFORMATION REASONABLY KNOWN AS OF 12-JUN-2017 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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 PLACEMENT OF A FEEDING TUBE WAS PERFORMED UTILIZING THE SYSTEM, WITH THE SMART RECEIVER UNIT POSITIONED ON THE CHEST AND SECURED WITH TAPE. THE INITIAL INSERTION WAS UNEVENTFUL. HOWEVER, POST PROCEDURE, AND X-RAY DISCOVERED THE FEEDING TUBE TO BE LOCATED IN THE LEFT LUNG. THE TUBE WAS IMMEDIATELY REMOVED AND REPLACED PER ORDERS. THE PATIENT DID NOT EXPERIENCE ANY PNEUMOTHORAX UPON REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425238 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT HALYARD HEALTH 20-0950 1308017 10815149024698

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR