BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRAGLIDE NASAL FEEDING TUBE

    MDR report key: 22293496 · Received June 19, 2025

    Report

    Report Number
    1526012-2025-00010
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 19, 2025
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071137991
    PMA / PMN Number
    K202539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION REPORTED TO AMT ON 05/29/2025, IT WAS DETERMINED THAT AN ADVERSE EVENT SHOULD BE REPORTED TO FDA AS A DUODENUM PERFORATION WAS FOUND IN THE SMALL INTESTINES OF THE PATIENT THREE DAYS AFTER A NUTRAGLIDE NASAL FEEDING TUBE PLACEMENT. THE INITIAL INFORMATION PROVIDED TO THE AMT SALES REPRESENTATIVE INDICATED THAT THE PATIENT WEIGHED LESS THAN 3KGS AND THAT THE 5-6 FRENCH SIZE WAS USED WITH A GUIDEWIRE FOR A POST PYLORIC PLACEMENT. AMT'S REQUESTS FOR FURTHER INFORMATION HAVE NOT BEEN FULFILLED BY THE HOSPITAL AT THIS TIME, AND THE DEVICE WAS NOT AVAILABLE FOR RETURN. ON 06/05/2025 AMT WAS NOTIFIED BY THE FDA OF MEDWATCH REPORT # (B)(4) WHICH WAS REPORTED BY THE HOSPITAL IN THIS EVENT. IN THE REPORT IT WAS NOTED THAT THE DEVICE WAS PLACED ON A PREMATURE INFANT WHO HAS A PREEXISTING MEDICAL CONDITION THAT MAY HAVE CONTRIBUTED TO THE EVENT. IT IS NOT BELIEVED THAT THE PERFORATION IS RELATED TO THE NUTRAGLIDE DEVICE. THE TUBE PLACEMENT FOLLOWS THE GUIDEWIRE THAT IS PLACED PREVIOUSLY TO THE TUBE PLACEMENT. THE INITIAL GUIDEWIRE PLACEMENT IS MOST LIKELY THE CAUSE FOR THE PERFORATION. IT WAS REPORTED THAT THE PATIENT MADE A FULL RECOVERY AFTER SURGERY. RECENT TRENDING DATA SHOWS THERE ARE NO SIMILAR REPORTED OCCURRENCES FROM ANY OTHER HOSPITALS. THE COMPLAINT INFORMATION HAS BEEN LOGGED INTO OUR COMPLAINT DATABASE FOR TRENDING PURPOSES. INFORMATION REGARDING DEVICE INVESTIGATION CAN BE FOUND UNDER COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    PER THE ORIGINAL REPORTER IN UF #: (B)(4), IT WAS REPORTED THAT A,"5 FRENCH 90CM NUTRAGLIDE NJT [NASOJEJUNAL TUBE] PLACED ON [REDACTED] FOR NUTRITION. THE PLACEMENT OF THIS TUBE WAS CONFIRMED BY X-RAY AND INSERTION WAS DONE PER HOSPITAL POLICY. ON [REDACTED], ABOUT THREE DAYS LATER, ABDOMINAL ULTRASOUND IDENTIFIED FREE FLUID NOTED IN ABDOMEN, GIVEN HCT [HEMATOCRIT] DROP, CONCERN FOR HEMOPERITONEUM. PATIENT TRANSFERRED EMERGENTLY TO ICU [INTENSIVE CARE UNIT], INTUBATED AND GEN SURGERY EXPLORATORY LAP IDENTIFIED FEEDS PRESENT IN INTRA-ABDOMINAL SPACE AND NJT FOUND TO HAVE GONE THROUGH INTESTINAL WALL ABOUT 1 CM AT THE D2-D3 JUNCTION RIGHT AS THE DUODENUM MAKES ITS TURN. INTESTINES ALL LOOKED HEALTHY, AND NO BOWEL HAD TO BE RESECTED. HOLE WAS SEWN SHUT AND ABDOMEN CLOSED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788196 NUTRAGLIDE NASAL FEEDING TUBE Tubes, gastrointestinal (and accessories) KNT APPLIED MEDICAL TECHNOLOGY, INC. ENFT-05090-I 241108-207 00842071137991

    Patients

    Seq Age Sex Outcome Treatment
    1 28 DA Male Other| R