BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CORTRAK NASOGASTRIC TUBE

    MDR report key: 21563722 · Received March 10, 2025

    Report

    Report Number
    9611594-2025-00049
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 7, 2025
    Report Date
    March 10, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 10 MAR 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, ¿NG [NASOGASTRIC] TUBE GOT BLOCKED, UNBLOCKING WAS ATTEMPTED USING LUCOZADE AND WARM WATER ¿ UNSUCCESSFUL. UPON REMOVAL THE NG SNAPPED/BROKE, AT THE 25CM MARK 25CM WAS RETAINED WITHIN THE PATIENT, PATIENT WENT FOR AN OESOPHAGOGASTRO DUODENOSCOPY (OGD) WHERE IT WAS REMOVED.¿ THE TUBE WAS IN-USE FOR THREE WEEKS. THE PATIENT¿S STATUS WAS REPORTED ¿NIL ISSUES.¿ PER ADDITIONAL INFORMATION RECEIVED ON 18FEB2025, ¿THE PATIENT NEEDED AN X RAY TO DETERMINE THE POSITION OF THE REMAINING NG AND AN OGD WAS REQUIRED TO REMOVE THE BROKEN NG. THE PATIENT MISSED FEEDS-SHE WAS FASTING FOR THREE DAYS THROUGHOUT THE EXPERIENCE BETWEEN THE BLOCKED TUBE AND THE OGD TO REMOVE SAME. THE PATIENT HAD TO UNDERGO BOTH AN X RAY AND AN OGD WHICH WOULD NOT HAVE BEEN INDICATED OTHERWISE. PATIENT IS STABLE. THE PATIENT WAS ON CONTINUOUS FEEDING. THE TUBE WAS USED FOR MEDICATION ADMINISTRATION. THE TUBE WAS FLUSHED BEFORE AND AFTER ANY MEDICATIONS AND BEFORE AND AFTER CONNECTING AND DISCONNECTING THE FEED. WE WOULD ESTIMATE THE TUBE WAS FLUSHED ABOUT 6 TIMES DAILY WITH STERILE WATER. A 60ML SYRINGE WAS USED TO FLUSH THE TUBE. THERE WERE NO ISSUES FLAGGED PRIOR TO THE TUBE BLOCKING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254650 UNKNOWN CORTRAK NASOGASTRIC TUBE DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female