BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE

    MDR report key: 20044199 · Received August 22, 2024

    Report

    Report Number
    9611594-2024-00157
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 23, 2024
    Report Date
    June 18, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460536
    PMA / PMN Number
    K220588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 21 AUG 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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 · 0

    ADDITIONAL INFORMATION: B3, B5, H6, H10 H10: MDR REPORT KEY (B)(4)/ MDR TEXT KEY (B)(4). ALL INFORMATION REASONABLY KNOWN AS OF 16 JUN 2025 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, ¿WE HAD AN INCIDENT IN WHICH THE CORTRAK TUBE STYLET PERFORATED THROUGH THE TUBE. NO HARM TO THE PATIENT EXCEPT THEY HAD SOME BLOODY SECRETIONS. NURSE WAS USING FLOPPY TIP TECHNIQUE AND WHEN SHE WENT TO ADVANCE THE STYLET IT POKED THROUGH THE TUBE. DID NOT MEET RESISTANCE. THE TUBE WAS COILED IN THE MOUTH SO IT WAS REMOVED. CHEST X-RAY WAS OKAY, NO PNEUMO. I THINK IT MAYBE WAS IN THE ESOPHAGUS AND NEVER MADE IT TO THE STOMACH IS WHAT IT SOUNDS LIKE.¿ PER ADDITIONAL INFORMATION RECEIVED ON 31JUL2024, FLOPPY TIP TECHNIQUE IS ¿A TECHNIQUE TO ADVANCE THE TUBE THAT MAKES THE END OF THE TUBE LESS STIFF. THE CLINICIAN UNSEATS THE STYLET, PULLS BACK THE STYLET ABOUT AN INCH, ADVANCES THE TUBE, THEN RESEATS THE STYLET.¿ NO MEDICAL INTERVENTIONS WERE REQUIRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 20MAY2025 FROM MEDWATCH/ FDA USER FACILITY REPORT MW REPORT (B)(4). "THE PATIENT WAS IN BURN OPERATING ROOM AND PROCEDURE WAS FINISHED. PRIOR TO THE PATIENT RETURNING TO ROOM ON BURN UNIT, THE RN WAS ASKED TO COME INSERT THE CORTRAK FEEDING TUBE WITH THE CORTRAK MACHINE. DURING THE INSERTION PROCESS, THE NURSE UTILIZED THE "FLOPPY TIP" TECHNIQUE TO TRY TO HELP IT ADVANCE. SHE PULLED THE STYLET BACK PARTIALLY, THEN WHEN SHE ADVANCED THE STYLET, IT PERFORATED THROUGH THE SIDE OF THE CORTRAK TUBE. THE KUB AND CHEST X-RAY SHOWED THE TUBE WAS COILED IN THE ESOPHAGUS. THERE WAS NO PNEUMOTHORAX OR ESOPHAGEAL PERFORATION SEEN ON X-RAY IMAGES. THE PATIENT HAD BLOODY SECRETIONS AND COUGHING OVER NIGHT BUT IT RESOLVED BY THE NEXT DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071061 CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. N/A UNKNOWN 00350770460536

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male