Stylet, tracheal tube: medical device reports filed with FDA

507 reports carry this product code, 1992–2026; 5 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

507
reports with this product code: 0% of all MAUDE reports; 9
reports, 12 months to August 2026: 24 in the 12 months before; 66.1%
classified as malfunction: 62.3% across all reports; 2%
classified as death, as reported: 0.9% across all reports

Product code BSR is FDA's classification for "Stylet, tracheal tube" (anesthesiology panel), a class 1 device. 507 medical device reports carry this product code, 0% of the MAUDE database, from November 1992 to August 2026.

9 reports arrived in the 12 months to August 2026, down 62% from 24 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (66.1%), injury (26%) and other (4.5%). 5 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Rusch	46	0	1.8%	89.8%
Mallinckrodt	33	1	1.2%	57.3%
Hudson RCI	2	121	1.3%	84.4%
Portex General Anesthesia Circuits	2	10	0%	99.4%
Endotracheal Tubes - Airway Management	1	0	0%	93.6%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Verathon Medical Ulc	53	10.5%
Mmj De Cv Usd	24	4.7%
Teleflex	16	3.2%
Covidien Juarez Mmj	11	2.2%
Unomedical Sdn Bhd	11	2.2%
Smiths Medical International	7	1.4%
Mallinckrodt Medical	4	0.8%
Covidien Formerly Tyco Healthcare	2	0.4%
Nellcor Puritan Bennett	2	0.4%
Covidien/Formerly Tyco Healthcare	1	0.2%
St Jude Medical - Neuromodulation	1	0.2%
Teleflex Medical Sdn Bhd	1	0.2%
Vyaire Medical	1	0.2%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death2%10

Injury26%132

Malfunction66.1%335

Other4.5%23

Not given1.4%7

Who filed

Manufacturer report77.1%391

Voluntary report8.3%42

User facility report0%0

Distributor report6.7%34

Not given7.9%40

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	88	17.4%
Difficult to removethe device was hard to remove	72	14.2%
Detachment of device component	46	9.1%
Material fragmentation	38	7.5%
Material separation	33	6.5%
Defective devicethe device was defective	23	4.5%
Detachment of device or device componentpart of the device came off	20	3.9%
Replace	19	3.7%
Difficult to insertthe device was hard to insert	18	3.6%
Sticking	17	3.4%
Device, removal of (non-implant)	15	3%
Tip breakage	15	3%
Crackthe device cracked	14	2.8%
Fracturea broken bone	14	2.8%
Component(s), broken	13	2.6%
Design/structure problem	12	2.4%
Loose	12	2.4%
Human-device interface problem	11	2.2%
Bent	8	1.6%
Failure to adhere or bond	8	1.6%

Questions about stylet, tracheal tube reports

What is product code BSR?

FDA's classification code for "Stylet, tracheal tube", class 1, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

507 reports through August 2026, 9 of them in the latest 12 months.

Which brands appear most often?

Rusch (46), Mallinckrodt (33), Hudson RCI (2), Portex General Anesthesia Circuits (2) and Endotracheal Tubes - Airway Management (1). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.