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

6,603 reports carry this product code, 1992–2026; 22 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.

6,603
reports with this product code: 0% of all MAUDE reports; 224
reports, 12 months to August 2026: 319 in the 12 months before; 62.9%
classified as malfunction: 62.3% across all reports; 2.5%
classified as death, as reported: 0.9% across all reports

Product code BTO is FDA's classification for "Tube, tracheostomy (w/wo connector)" (anesthesiology panel), a class 2 device. 6,603 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to August 2026.

224 reports arrived in the 12 months to August 2026, down 30% from 319 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 (62.9%), injury (32.9%) and death (2.5%). 22 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	793	1,513	1.1%	74.5%
Portex	230	8	0.6%	80.6%
Portex Blue Line Ultra Tracheostomy Tube	169	30	0%	69.7%
Portex Tubes BLUselect Suctionaid	141	72	0.6%	92%
Shiley Low Pressure Cuffed	130	0	0.4%	12.6%
Portex General Anesthesia Circuits	127	10	0%	99.4%
Shiley Disposable Cannula Low Pressure	122	0	0.8%	4%
Bivona	81	11	1%	73.7%
Bivona Tracheostomy Tube Neonatal/Pediatric	65	7	0.9%	77.2%
Shiley Fenestrated Low Pressure Cuffed	46	0	0%	6.1%
Mallinckrodt	41	1	1.2%	57.3%
Portex Endotracheal Tube	12	25	0%	75.8%
Portex Endotracheal Tubes	7	36	0.4%	82.5%
Fluency Plus Tracheobronchial Stent Graft	3	0	0%	90.7%
AirLife	1	37	2.6%	61.3%
Bivona Customized Tracheostomy Tubes	1	24	1%	80.5%
Catheter	1	9	3.7%	27.9%
Laryngeal Mask Airway	1	0	2.1%	64.8%
Medline	1	26,184	0.1%	97.9%
Pneupac Parapac Ventilator	1	0	0.4%	94.2%
Portex Tracheal Tube Clear Murphey Eyesoft Seal	1	118	0.4%	88.5%
Rusch	1	0	1.8%	89.8%

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
Smiths Medical International	1,414	21.4%
Mallinckrodt Medical	592	9%
Smiths Medical Asd	545	8.3%
Covidien/Formerly Tyco Healthcare	401	6.1%
Covidien Formerly Tyco Healthcare	211	3.2%
Smiths Healthcare Manufacturing De C V	123	1.9%
Smiths Medical	104	1.6%
Mmj De Cv Usd	78	1.2%
Icu Medical Healthcare Manufacturing De C V	64	1%
Nellcor Puritan Bennett	41	0.6%
Smith S Medical Asd	20	0.3%
Covidien Juarez Mmj	8	0.1%
Icu Medical	8	0.1%
Teleflex Medical Sdn Bhd	6	0.1%
Respironics California	2	0%

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

Death2.5%163

Injury32.9%2,175

Malfunction62.9%4,153

Other1.1%70

Not given0.6%42

Who filed

Manufacturer report91.8%6,060

Voluntary report3.1%205

User facility report0%0

Distributor report1%65

Not given4.1%273

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

Device problems coded

Device problem (FDA code)	Reports	Share
Air leak	898	13.6%
Replace	807	12.2%
Leak/splashthe device leaked	643	9.7%
Inflation problem	565	8.6%
Breakthe device broke	452	6.8%
Gas/air leak	447	6.8%
Device, removal of (non-implant)	318	4.8%
Material separation	263	4%
Crackthe device cracked	255	3.9%
Detachment of device component	165	2.5%
Disconnection	154	2.3%
Difficult to insertthe device was hard to insert	138	2.1%
Deflation problem	136	2.1%
Detachment of device or device componentpart of the device came off	133	2%
Component(s), broken	126	1.9%
Fitting problem	106	1.6%
Inadequacy of device shape and/or size	102	1.5%
Defective component	95	1.4%
Deflation, cause unknown	88	1.3%
Fracturea broken bone	86	1.3%

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

What is product code BTO?

FDA's classification code for "Tube, tracheostomy (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?

6,603 reports through August 2026, 224 of them in the latest 12 months.

Which brands appear most often?

Shiley (793), Portex (230), Portex Blue Line Ultra Tracheostomy Tube (169), Portex Tubes BLUselect Suctionaid (141) and Shiley Low Pressure Cuffed (130). 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.