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Device brand name · Tube tracheal w/wo connector
Endotracheal Tubes - Airway Management: medical device reports filed with FDA
203 reports name it, 2013–2017. Manufacturer given most often on reports: Unomedical Sdn Bhd. Product code BTR.
- 203
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 93.6%
- classified as malfunction
- 76.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 203 reports that name the brand "Endotracheal Tubes - Airway Management" (tube tracheal w/wo connector), received between October 2013 and September 2017; the manufacturer given most often on reports is Unomedical Sdn Bhd. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (93.6%) and injury (6.4%); across all tube, tracheal (w/wo connector) reports (product code BTR) death is recorded in 1.3% and malfunction in 76.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device contamination with chemical or other material (35.5%), device contaminated during manufacture or shipping (9.4%) and air leak (6.4%). The patient problems coded most often are no patient involvement, hypoventilation and edema. 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."
Reports by month, five years
No report naming Endotracheal Tubes - Airway Management was received in the five years to August 2026; the latest was received in September 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 19,171 reports carrying product code BTR. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device contamination with chemical or other material | 72 | 35.5% | 1.8% |
| Device contaminated during manufacture or shipping | 19 | 9.4% | 0.2% |
| Air leak | 13 | 6.4% | 5.4% |
| Material deformation | 13 | 6.4% | 0.9% |
| Inflation problem | 11 | 5.4% | 11.5% |
| Packaging problem | 10 | 4.9% | 0.4% |
| Defective devicethe device was defective | 9 | 4.4% | 0.5% |
| Leak/splashthe device leaked | 9 | 4.4% | 7% |
| Tear, rip or hole in device packaging | 9 | 4.4% | 0.3% |
| Kinkedthe tube or line kinked | 4 | 2% | 2% |
| Device markings/labelling problema problem with the device markings or label | 3 | 1.5% | 1.6% |
| Deflation problem | 2 | 1% | 4% |
| Disconnection | 2 | 1% | 3.9% |
| Incomplete or missing packaging | 2 | 1% | 0% |
| Misassembled | 2 | 1% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 13 | 6.4% |
| Hypoventilation | 3 | 1.5% |
| Edemaswelling from fluid | 2 | 1% |
| Airway obstruction | 1 | 0.5% |
| Irritationirritation | 1 | 0.5% |
| Not applicable | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endotracheal Tubes - Airway Management | Product code BTR | All MAUDE reports |
|---|---|---|---|
| Reports | 203 | 19,171 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 13 | 9 |
| Classified as injury | 6.4% | 19.9% | 36.2% |
| Classified as malfunction | 93.6% | 76.6% | 62.3% |
| Filed by the manufacturer | 100% | 94.1% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code BTR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Shiley | 12,236 | 1,513 | 1.1% |
| Mallinckrodt | 3,105 | 1 | 1.2% |
| TaperGuard | 933 | 124 | 0.4% |
| Curity | 664 | 18 | 0.2% |
| Portex Tracheal Tube Clear Murphey Eyesoft Seal | 243 | 118 | 0.4% |
| Portex | 970 | 8 | 0.6% |
| Portex Endotracheal Tube | 281 | 25 | 0% |
| Portex Endotracheal Tubes | 223 | 36 | 0.4% |
| Salter Labs | 168 | 15 | 0.6% |
| Avanos | 170 | 38 | 1.2% |
| Rusch | 285 | 0 | 1.8% |
| Hudson RCI | 224 | 121 | 1.3% |
| Halyard | 156 | 11 | 1.3% |
| Bivona | 768 | 11 | 1% |
| Laryngeal Mask Airway | 617 | 0 | 2.1% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Endotracheal Tubes - Airway Management reports
How many FDA reports name Endotracheal Tubes - Airway Management?
203 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (93.6%) and injury (6.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device contamination with chemical or other material (35.5%), device contaminated during manufacture or shipping (9.4%), air leak (6.4%), material deformation (6.4%) and inflation problem (5.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Endotracheal Tubes - Airway Management was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.