Tube, tracheal (w/wo connector): medical device reports filed with FDA

19,171 reports carry this product code, 1992–2026; 28 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.

19,171
reports with this product code: 0.1% of all MAUDE reports; 1,652
reports, 12 months to August 2026: 1,737 in the 12 months before; 76.6%
classified as malfunction: 62.3% across all reports; 1.3%
classified as death, as reported: 0.9% across all reports

Product code BTR is FDA's classification for "Tube, tracheal (w/wo connector)" (anesthesiology panel), a class 2 device. 19,171 medical device reports carry this product code, 0.1% of the MAUDE database, from April 1992 to August 2026.

1,652 reports arrived in the 12 months to August 2026, close to the 1,737 of 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 (76.6%), injury (19.9%) and other (1.8%). 28 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
Shiley	4,760	1,513	1.1%	74.5%
Mallinckrodt	2,113	1	1.2%	57.3%
TaperGuard	932	124	0.4%	86.4%
Curity	629	18	0.2%	92%
Portex Tracheal Tube Clear Murphey Eyesoft Seal	242	118	0.4%	88.5%
Portex	235	8	0.6%	80.6%
Portex Endotracheal Tube	217	25	0%	75.8%
Portex Endotracheal Tubes	212	36	0.4%	82.5%
Endotracheal Tubes - Airway Management	202	0	0%	93.6%
Salter Labs	38	15	0.6%	84.5%
Avanos	33	38	1.2%	91.2%
Rusch	29	0	1.8%	89.8%
Hudson RCI	25	121	1.3%	84.4%
Halyard	17	11	1.3%	94.9%
Bivona	16	11	1%	73.7%
Laryngeal Mask Airway	15	0	2.1%	64.8%
Medline	2	26,184	0.1%	97.9%
Tenax	2	0	0.9%	31.6%
Baxter	1	3	3.8%	54.2%
Catheter	1	9	3.7%	27.9%
Covidien	1	30	1.4%	45.5%
Medtronic	1	17	4.4%	23.5%
Nellcor	1	215	3.9%	89.3%
Ni	1	1,587	1.8%	29.5%
Pneupac	1	0	0%	97.1%
Portex Blue Line Ultra Tracheostomy Tube	1	30	0%	69.7%
Portex Tubes BLUselect Suctionaid	1	72	0.6%	92%
Unknown Suture Product	1	28	0.9%	45.3%

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
Mmj De Cv Usd	3,973	20.7%
Teleflex Medical	2,517	13.1%
Covidien Juarez Mmj	2,095	10.9%
Smiths Medical International	1,116	5.8%
Unomedical Sdn Bhd	997	5.2%
Covidien	938	4.9%
Avanos Medical	589	3.1%
Smiths Medical Asd	431	2.2%
Mallinckrodt Medical	420	2.2%
Smiths Healthcare Manufacturing De C V	395	2.1%
Teleflex Medical Sdn Bhd	343	1.8%
Teleflex	331	1.7%
Halyard Health	215	1.1%
Covidien Formerly Tyco Healthcare	169	0.9%
Covidien/Formerly Tyco Healthcare	165	0.9%

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

Death1.3%256

Injury19.9%3,815

Malfunction76.6%14,693

Other1.8%348

Not given0.3%59

Who filed

Manufacturer report94.1%18,034

Voluntary report2.1%406

User facility report0%0

Distributor report0.5%92

Not given3.3%639

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

Device problems coded

Device problem (FDA code)	Reports	Share
Gas/air leak	3,068	16%
Inflation problem	2,199	11.5%
Leak/splashthe device leaked	1,337	7%
Air leak	1,038	5.4%
Deflation problem	759	4%
Disconnection	750	3.9%
Material split, cut or torn	660	3.4%
Defective component	546	2.8%
Breakthe device broke	408	2.1%
Kinkedthe tube or line kinked	374	2%
Connection problema connection problem	353	1.8%
Device contamination with chemical or other material	353	1.8%
Replace	323	1.7%
Detachment of device or device componentpart of the device came off	311	1.6%
Device markings/labelling problema problem with the device markings or label	305	1.6%
Device operates differently than expectedthe device behaved unexpectedly	249	1.3%
Detachment of device component	244	1.3%
Material separation	218	1.1%
Material integrity problema problem with the device material	202	1.1%
Material puncture/hole	194	1%

Questions about tube, tracheal (w/wo connector) reports

What is product code BTR?

FDA's classification code for "Tube, tracheal (w/wo connector)", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

19,171 reports through August 2026, 1,652 of them in the latest 12 months.

Which brands appear most often?

Shiley (4,760), Mallinckrodt (2,113), TaperGuard (932), Curity (629) and Portex Tracheal Tube Clear Murphey Eyesoft Seal (242). 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.