MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. NUTRAGLIDE NASAL FEEDING TUBE; Tubes, gastrointestinal (and accessories)

Model Number	ENFT-05090-I
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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".
Additional Manufacturer Narrative
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).

• Brand Name: NUTRAGLIDE NASAL FEEDING TUBE
• Common Device Name: Tubes, gastrointestinal (and accessories)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: ellyn smith ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 22293496
• Report Number: 1526012-2025-00010
• Device Sequence Number: 8373988
• Product Code: KNT
• UDI-Device Identifier: 00842071137991
• UDI-Public: 00842071137991
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K202539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ENFT-05090-I
• Device Catalogue Number: ENFT-05090-I, NFT-05090-I
• Device Lot Number: 241108-207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 28 DA
• Patient Sex: Male
• Patient Weight: 3 KG