BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE

    MDR report key: 19180563 · Received April 25, 2024

    Report

    Report Number
    9611594-2024-00065
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    March 16, 2024
    Report Date
    July 11, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460536
    PMA / PMN Number
    K220588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 22 APR 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

    UDI-PI IS UNAVAILABLE AS NO LOT NUMBER WAS PROVIDE FOR THE REPORTED EVENT. ALL INFORMATION REASONABLY KNOWN AS OF 10 JUL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED "I WANTED YOU TO KNOW THAT WE HAD AN EVENT WITH A DOBHOFF TUBE (DHT) OCCURRED WHERE THE DHT BECAME FRACTURED AND HAD TO BE REMOVED. THE DHT WAS PLACED ON 19-FEB-2024 AND THE EVENT OCCURRED ON 16-MAR-2024. 64- YEAR-OLD FEMALE WHO HAS A HISTORY OF A NECROTIZING SOFT TISSUE INFECTION OF HER LOWER ABDOMEN WHICH REQUIRED SEVERAL EXCISIONS. SHE HAS HAD A TRANSPYLORIC FEEDING TUBE WHICH WAS FOUND TO HAVE FRACTURED LEAVING A RETAINED FOREIGN BODY IN THE DISTAL STOMACH AND DUODENUM. SHE REQUIRED REMOVAL OF THE DISTAL FRAGMENT OF HER DOBHOFF TUBE. THERE WAS APPROXIMATELY 40 CM (APPROXIMATELY 15.7 INCHES) OF DOBHOFF TUBE IDENTIFIED IN THE DISTAL STOMACH AND DUODENUM WHICH WAS REMOVED. THE PATIENT WAS IN SURGICAL ICU. IT WAS SEEN ON X-RAY FOR KIDNEY, URETER, AND BLADDER (KUB). THE TUBE HAD BEEN IN PLACE FOR NEARLY A MONTH. IT WAS PLACED BY THE CORTRAK TEAM. THERE IS A COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2024 SHOWING FEEDING TUBE WITH TIP IN THE PROXIMAL JEJUNUM. NO FRACTURE NOTED. ON 16-MAR-2024 IT WAS FOUND.¿ PER ADDITIONAL INFORMATION RECEIVED ON 04-APR-2024, ¿DHT STOPPED FUNCTIONING AND IT WAS DISCOVERED ON IMAGING THAT THE DISTAL PORTION OF THE DHT HAD FRACTURED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH FOREIGN BODY REMOVAL. NO INJURY OCCURRED TO THE PATIENT.¿ ON 16-MAR-2024 AT 0300, REGISTERED NURSE (RN) NOTED DHT CLOGGED. AT 1047, CONCERN PER MD, DHT IS BROKEN OFF. CLOG ZAPPER ORDERED ON 16-MAR-2024 AND DISCONTINUED ON DISCHARGED, 24-MAR-2024. THERE WERE NO CRUSHED MEDICATIONS ADMINISTERED VIA THE TUBE. PATIENT WAS GETTING FREE WATER 250 ML EVERY 6 HOURS. PATIENT ALSO RECEIVED ROUTINE FLUSHES. FLUSH BEFORE, BETWEEN, AND AFTER MEDICATION ADMINISTRATION. FLUSH PROVIDED ANYTIME A CONTINUOUS FEEDING IS INTERRUPTED. THE TUBE WAS FLUSHED WITH A VOLUME SUFFICIENT TO CLEAR THE TUBE. A 60-CC SYRINGE IS USUALLY USED. THE PATIENT¿S STATUS WAS REPORTED TO BE DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856178 CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9551TRAK2 UNKNOWN 00350770460536

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female 60-CC SYRINGE.| CLOG ZAPPER.