BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS

    MDR report key: 19351286 · Received May 20, 2024

    Report

    Report Number
    19351286
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    February 23, 2024
    Report Date
    March 7, 2024
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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
    1616209 AVANOS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. 40-9438

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male