BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 11790454 · Received May 7, 2021

    Report

    Report Number
    3011270181-2021-00024
    Event Type
    Injury
    Date Received
    May 7, 2021
    Report Date
    May 24, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 19-MAY-2021 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 · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 23-MAY-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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 29-APR-2021 NOTED "THE INTERNAL INVESTIGATION AND THE SURGICAL TEAM AT THE [USER FACILITY] HAS DETERMINED THAT THE PATIENT INJURY WAS MOST LIKELY NOT TO HAVE BEEN CAUSED BY THE CORTRAK FEEDING TUBE [AND THAT THE INJURY WAS MOST PROBABLY CAUSED BY SURGICAL INSTRUMENTATION DURING A LAPAROSCOPIC PROCEDURE."

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED NG TUBE WITH TRANSMITTING STYLET WAS RECEIVED. THE CORTRAK 2 ENTERAL ACCESS SYSTEM WAS NOT RETURNED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 1204044, 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 07-MAY-2021 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. 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 THERE WAS "A PATIENT ON THE BURN UNIT THAT HAD A DUODENAL ULCER, VOMITED UP HIS CORTRAK, WENT TO SURGERY WHERE THEY FOUND A 2CM PERFORATION OF THE ANTERIOR PORTION OF THE 1ST PART OF THE DUODENUM AND A SMALL PERFORATION OF THE GALL BLADDER...THE SURGICAL NOTE STATES THEY THINK IT COULD HAVE BEEN CAUSED BY THE ENDOSCOPY OR BY A WIRE." ADDITIONAL INFORMATION RECEIVED 28-APR-2021 STATED THE DEVICE WAS PLACED (B)(6) 2021 AT 10:23. THE EVENT DATE TIME FRAME WAS (B)(6) 2021. THE INCIDENT WAS IDENTIFIED BY THE PATIENT VOMITING "FRANK BLOOD." A FOLLOW-UP X-RAY NOTED A BLEEDING ULCER. THE PATIENT UNDERWENT ENDOSCOPY AND SURGERY ON (B)(6) 2021 07:30. THE SERIES OF EVENTS NOTED THE "PATIENT HAD GI BLEED, SCOPED WHERE AN OOZING DUODENAL ULCER WAS FOUND IN THE DUODENAL BULB MEASURING 30MM. PATIENT TAKEN TO SURGERY WHERE A 2CM LACERATION OF THE 1ST PART OF THE DUODENUM AND A SMALL PERFORATION OF THE GALL BLADDER WERE FOUND." "OF NOTE: THE TUBE WAS CUT AT THE BRIDLE EMERGENTLY WHEN PATIENT WAS VOMITING BLOOD. THE ORIGINAL DEPTH WAS 101 CM. THE TUBE WAS RETRACED ABOUT AN HOUR AFTER PLACEMENT DUE TO A KINK IN THE TUBE AFTER THE REPOSITION, THE TUBE WAS LEFT AT 94 CM." THE CLINICIANS COULD NOT FIND ANY PERFORATIONS. INCONCLUSIVE FEEDING TUBE VS ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686879 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention SMART RECEIVER UNIT #1308045