MAUDE Adverse Event Report: UTAH MEDICAL, INC. NUTRI-CATH WITH NUTRI-LOK SILICONE FEEDING TUBE; TUBES, GASTROINTESTINAL AND ACCESSORIES

Model Number 4155037

Device Problem Obstruction of Flow (2423)

Patient Problem No Information (3190)

Event Date 12/26/2018

Event Type  malfunction  

Event Description

Nasogastric tube occluded during infant feeding and had to be removed and replaced.

• Brand Name: NUTRI-CATH WITH NUTRI-LOK SILICONE FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL AND ACCESSORIES
• Manufacturer (Section D): UTAH MEDICAL, INC.; midvale UT 84047
• MDR Report Key: 8231143
• MDR Text Key: 133056401
• Report Number: MW5082949
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2023
• Device Model Number: 4155037
• Device Lot Number: 1182191
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 MO