BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO NASOGASTRIC NASOINTESTINAL PEDIATRIC FEEDING TUBE WITH STYLET WITH ENFIT

    MDR report key: 14371236 · Received May 12, 2022

    Report

    Report Number
    14371236
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    February 19, 2022
    Report Date
    April 28, 2022
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD NASOGASTRIC TUBE (NGT). NOTED TO HAVE EPISODES OF NGT BEING CLOGGED, EVENTUALLY FLUSHED/CLEARED WITH SODA. HE VOMITED THE TUBE OUT AROUND DAY +4; PER PARENTS REPORT IT WAS NOTED THAT THE TIP OF THE NGT SEEMED FLAYED AT THE END. HE HAS HAD SUBSEQUENT NGTS. APPROXIMATELY 12 DAYS LATER, HE HAD A X-RAY TAKEN FOR PLACEMENT OF ANOTHER NGT. RADIOLOGY REPORT COMMENTED THAT THERE APPEARED TO BE A PART OF A TUBE THAT MAYBE EXTERNAL TO THE PATIENT. FOLLOW-UP X-RAY CONFIRMED THAT HE HAD A PIECE OF NGT IN HIS SMALL INTESTINES. THE PATIENT HIMSELF HAS HAD ABOUT 48 HOURS OF STRAINING AND SEEMING UNCOMFORTABLE WITH STOOLING. APPROXIMATELY 3 DAYS LATER , THE PATIENT UNDERWENT A COLONOSCOPY WITH GI, WHERE PROVIDERS WERE UNABLE TO RETRIEVE THE OBJECT FROM THE PATIENT'S SMALL INTESTINE. THE PIECE WAS EXTRACTED IN THE OR VIA LAPAROSCOPIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956094 CORFLO NASOGASTRIC NASOINTESTINAL PEDIATRIC FEEDING TUBE WITH STYLET WITH ENFIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. 40-8366

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA Male Other| H| R