Complications Associated With AMT Nasal Bridle Use: An FDA MAUDE Analysis

Area of Science:

• Medical Devices
• Patient Safety
• Clinical Practice

Background:

• Nasal bridles are increasingly used for nasogastric tube security.
• They aim to prevent dislodgement and improve caloric intake in hospital settings.

Purpose of the Study:

• To analyze patient-related adverse events linked to nasal bridle use.
• To identify common complications and their classifications.

Main Methods:

• Utilized the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
• Reviewed adverse events reported between 2000 and 2023.

Main Results:

• Identified 24 unique adverse events: foreign body retention (15), septal laceration (4), septal tears (3), skin irritation (1), and pressure necrosis (1).
• Classified events as device malfunction (14), patient-related injury (9), and other (1).

Conclusions:

• Nasal bridles, while beneficial, pose risks including device malfunction and patient injury.
• Awareness of potential adverse events is crucial for clinicians to ensure safe patient care.