BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE W/ STYLET W/ ENFIT CONNECTOR

    MDR report key: 19546560 · Received June 17, 2024

    Report

    Report Number
    9611594-2024-00114
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    February 23, 2024
    Report Date
    June 14, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460505
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 11 JUN 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 VIA FDA REPORT (B)(4),¿ PATIENT HAD NEW FREQUENT EMESIS DURING DAYSHIFT AND AT THE CHANGE OF SHIFT HE CONTINUED TO HAVE MORE EMESIS, COLOR WAS CLEAR/OPAQUE, VOLUME WAS LARGE AT THE START OF SHIFT. REGISTERED NURSE (RN) PAUSED THE FEEDS. HIS NASOJEJUNAL TUBE (NJT) CAME OUT ABOUT TWO INCHES OUT HIS NOSE; RN RE-TAPED THE NJT TUBE. RN UPDATED THE PROVIDER REGARDING THE EMESIS AND HOW IT SMELLED SLIGHTLY LIKE FORMULA AND ASKED TO ORDER A KIDNEY, URETER, AND BLADDER (KUB) X-RAY. PATIENT CONTINUED TO BE UNCOMFORTABLE AND FREQUENTLY COUGHED, GAGGED AND VOMITED, WHICH BECAME GREEN IN COLOR AND LESS VOLUME. AFTER THE MDS VIEWED THE KUB, THERE SEEMED TO BE A KINK IN THE TUBE AND SO DECIDED TO REMOVE THE NJT. AFTER RN REMOVED IT, NJT WAS FULLY INTACT; HOWEVER, AT THE KINK THERE WAS THINNING OF THE NJT AND AN OPEN SLIT; MDS WERE NOTIFIED. PATIENT FELT MUCH MORE COMFORTABLE AND STOPPED COUGHING AND GAGGING AFTER NJT REMOVED. PER MD, PATIENT TO TRANSITION TO IV MEDS AND IV FLUIDS FOR THE NIGHT. PRODUCT HAD KINK WITH WEAKENED TUBE INTEGRITY, PRODUCT DISPOSED.¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331817 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE W/ STYLET W/ ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9438 UNKNOWN 00350770460505

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male