MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. NUTRAGLIDE NASAL FEEDING TUBE; NUTRAGLIDE NASAL FEEDING TUBE WITH STYLET AND ENFIT

Model Number	NFT-08110-I
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to medwatch report #mw5184947 which was received by amt from the fda on 04/06/2026.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Since the device was not available for return, a visual and functional evaluation could not be performed, and the device failure could not be confirmed.Based on the provided information the reported problem is not believed to have been caused by a manufacturing defect.This is an isolated event as this is the first and only report of its kind.The complaint information has been logged into our complaint database for trending purposes.Information regarding device investigation can be found under complaint #(b)(4).
Event or Problem Description
Per the original reporter in medwatch report #: mw5184947, it was reported that the "guidewire perforated dht during placement resulting in the guidewire extending out the side of the dht and into the stomach".

• Brand Name: NUTRAGLIDE NASAL FEEDING TUBE
• Common Device Name: NUTRAGLIDE NASAL FEEDING TUBE WITH STYLET AND ENFIT
• 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 dipaolo ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 25080316
• Report Number: 1526012-2026-00008
• Device Sequence Number: 10418920
• Product Code: KNT
• UDI-Device Identifier: 00842071151225
• UDI-Public: 00842071151225
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NFT-08110-I
• Device Catalogue Number: NFT-08110-I
• Device Lot Number: 260206-227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/05/2026
• 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
• Patient Age: 22 YR
• Patient Sex: Male