BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMIT

    MDR report key: 8855636 · Received August 2, 2019

    Report

    Report Number
    9611594-2019-00147
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 11, 2019
    Report Date
    October 3, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. ONE USED SAMPLE WAS RECEIVED WITHOUT PRODUCT PACKAGING; THE PRODUCT DOES NOT CONTAIN A LOT NUMBER IDENTIFICATION. THE TUBING EXHIBITS "BALLOONING" WITH COMPLETE RUPTURE AT THE 33CM MARK. BOTH SEGMENTS WERE FOUND TO BE COMPLETELY OCCLUDED WITH DRIED MATTER. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A POTENTIAL CAUSE IS USE ERROR AS PER THE INSTRUCTIONS FOR USE, VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS, OR UNBLOCK THE TUBE. ALL INFORMATION REASONABLY KNOWN AS OF 02 OCT 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 HALYARD HEALTH 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 PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 02 AUG 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. 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NG [NASOGASTRIC] TUBE HAD "A HOLE IN IT." THE ISSUE WAS NOTICED DURING A KUB [KIDNEY-URINARY-BLADDER X-RAY]." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 29-JUL-2019 INDICATED THE "TUBE DID NOT BREAK INTO TWO PIECES, ALTHOUGH IT IS HANGING BY A 'THREAD,' APPEARS IT BALLOONED OUT & BURST...TUBE REMOVED MANUALLY." DEVICE WAS PLACED ON (B)(6) 2019 AT 2121 AND WAS REMOVED ON (B)(6) 2019. THE PACKAGING WAS NOT SAVED. THE DEVICE WAS NOT REPROCESSED OR REUSED. "NO PROBLEMS WITH DEVICE, ISSUE WAS FOUND INCIDENTALLY VIA XRAY. PATIENT WAS GETTING AN XRAY TO ASSESS STOOL BURDEN...PATIENT RECEIVING CONTINUOUS TUBE FEED VIA DHT [DOBHOFF TUBE] AT 120ML/HR. NO ISSUES IDENTIFIED WITH FLUSHING OR ROUTINE USE OF DHT." NO OTHER DEVICES OR THERAPIES WERE BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PATIENT STATUS WAS REPORTED AS "NO ILL EFFECTS THAT WE KNOW OF, DISCHARGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649103 CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMIT DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 40-9551TRAK2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR