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

ABSTRACT

Nasal bridles have been used with increasing frequency and can be deployed at bedside. They are effective in reducing dislodgement of nasogastric tubes in the hospital setting and may increase caloric intake. Adverse events associated with device malfunction or improper use can occur and have a detrimental effect on patients. This study utilized the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to explore patient‐related adverse events associated with nasal bridle use between 2000 and 2023. Twenty‐four unique adverse events were reported: 15 were associated with foreign body retention, 4 with septal laceration on placement or removal, 3 from septal tears secondary to forceful patient removal, 1 associated with skin irritation, and 1 pressure necrosis. Fourteen of the 24 events were classified as device malfunction, 9 as patient‐related injury, and 1 as other. Despite their usefulness, they are not without risks, and clinicians should be aware of the potential issues.

1. Introduction

Applied Medical Technology's (AMT) Bridles & Bridle Pro's are medical devices used to secure nasogastric (NG) tubes in patients requiring enteric feedings [1]. These devices have been used with increasing frequency and can be deployed at the bedside. Proper use of these securing devices can reduce NG tube dislodgments and inadvertent removal, two commonly encountered issues with existing securement methods (i.e., suturing the nasogastric tube to the septum or taping the tube to the face) [2, 3]. However, adverse events associated with bridle device malfunction or improper use can occur and have a detrimental effect on patients. Through this study, we utilize the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to explore patient‐related adverse events associated with AMT Bridle use.

2. Methods

The MAUDE database was queried for key terms “AMT Bridle” “Bridle” & “Bridle Pro” to identify adverse events associated with bridle use. Reports from January 1, 2000–October 5, 2023 were collected for analysis. Duplicate reported events were determined by similar date of submission, categorization of adverse events, and adverse event descriptions. These duplicate submissions were subsequently excluded from analysis. Aggregate descriptions of recorded variables, such as patient‐reported problems, event types, summaries, and needs for additional intervention, were pulled from the provided MAUDE database. The Stanford International Review Board (IRB) board exempted this study from review given the public nature of this data.

3. Results

Thirty‐one adverse events were reported in the MAUDE database. Of these 31 reported events, 7 were duplicates and removed, yielding 24 unique events (Supporting Information S1: S1). Of the 24 reported adverse events, 15 were associated with foreign body retention, 4 with septal laceration on placement or removal, 3 from septal tears secondary to forceful patient removal, 1 associated skin irritation, and 1 pressure necrosis (Figure 1). Fourteen of the 24 events were classified as device malfunction, 9 as patient‐related injury, and 1 other (Table 1). Half (12) of the reported adverse events through the MAUDE database required some sort of surgical intervention, most often associated with additional imaging (8), and/or general anesthesia (9).

Figure 1.

Breakdown of patient‐reported problems by percentage of total reported incidents.

Table 1.

Patient outcomes.

Patient reported problem	N (%)
Foreign body	15 (62.5)
Laceration with placement/removal	4 (16.6)
Septal tear from forceful removal	3 (12.5)
Skin irritation	1 (4.2)
Pressure necrosis	1 (4.2)
Event type
Malfunction	14 (58.3)
Injury	9 (37.5)
Other	1 (4.17)
Surgical intervention required	12 (50)
Additional imaging	8 (33.3)
General anesthesia	9 (37.5)

In our study, out of 12 patients necessitating surgical procedures, 3 encountered life‐threatening events secondary to bridle‐related adverse events. The initial event involved a patient forcefully removing the bridle, resulting in a tearing of the nasal septum. The severe hemorrhage that ensued necessitated multiple interventions, intubation, and ICU management. In the second case, a patient similarly attempted a forceful removal of the bridle, leading to tearing of the nasal septum and a subsequent life‐threatening hemorrhage. Rapid surgical interventions were performed at the bedside to stabilize this patient's condition. Finally, the third patient once again attempted to extract the bridle forcefully, resulting in a nasal septal tear. The third patient experienced hemorrhage and aspiration leading to emergent intubation and evacuation of tracheal clots.

4. Discussion

Nasal bridles are a useful tool that is effective in reducing dislodgement of the NG tube in inpatient hospital settings [4]. The bridle has been shown advantageous under circumstances where other securement methods fail (Figure 2). Other securement methods (e.g., suturing nasogastric tubes to the septum or taping the nasogastric tube to the face), additionally, are fraught with potential complications, such as bleeding risks, retained foreign objects, and ineffectiveness. In a meta‐analysis performed by Bechold et al. nasal bridles were shown to significantly reduce tube dislodgements compared to tape [OR], 0.16; [0.10–0.27]; p < 0.01 [2]. Seder et al. additionally showed that bridled patients are more likely to reach their daily caloric goals compared to their unbridled counterparts [5]. Despite the bridle's usefulness, however, it is not without risks, which in very rare cases can be life threatening. As the use of these bridles becomes more commonplace due to their user‐friendliness and efficacy, it is important to consider patient populations that are at higher risk for iatrogenic evulsions. Considerations should be given to management with face tapes or sutures versus bridling systems in patients who may lack the capacity to avoid tugging at or pulling on these devices. Septal tearing secondary to attempted forceful removal can be life‐threatening due to high‐volume epistaxis. Low‐volume bleeding may resolve spontaneously or with a topical decongestant. Large‐volume arterial bleeding may require posterior nasal packing and potentially sphenopalatine artery (SPA) ligation, given the contribution of the posterior septal branch of the SPA to this region of the septum. Otolaryngologists should similarly be aware of the potentially negative impact these devices can impart on patients, as they are frequently the ones emergently consulted to manage these adverse events.

Figure 2.

Demonstration of bridle use. Created in BioRender. Grimm, D. (2025). https://BioRender.com/q69i210.

These devices should also be acknowledged as a rare source of retained foreign objects. In a case study described by Inaytat et al. following placement of a nasal bridle, the magnetic tip detached and lodged itself in the sphenoid sinus necessitating endoscopic sinus surgery for removal [6]. A similar case report by Jackson et al. described a series of two patients where a retained stylet was identified and removed [7]. The incidence of retained foreign objects appears low, but the potential for such occurrences warrants heightened awareness from providers who frequently use these devices. Additional caution is recommended for patients with a known propensity for epistaxis.

This study is not without limitations. A significant limitation is that while adverse events are required to be reported by manufacturers, they are only voluntarily reported by providers making underreporting likely. However, the overall low number of reported adverse events does appear to be low, suggesting that nasal bridles are safe in the majority of patients. Another inherent limitation is that publicly reported data in MAUDE databases frequently lack detailed descriptions of patient‐related health information, such as demographic, comorbidity, and other adverse event‐related history.

5. Conclusion

Nasal bridles are an increasingly common source of retained foreign objects. In rare cricumstances, they can additionally cause life‐threatening side ffects that otolaryngologists should be made aware of.

Author Contributions

All authors read and approved the final manuscript. David R. Grimm: data analysis, manuscript drafting, manuscript revision. Douglas R. Sidell: manuscript drafting and manuscript revision. Noel F. Ayoub: conception, study design, data analysis, manuscript drafting, manuscript revision.

Ethics Statement

This study was deemed to be exempt from review by the Stanford IRB given the public nature of this data set.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Supplement_1_NB.

Data Availability Statement

Data available on request.