Devices › Tube, tracheal (w/wo connector)
Device brand name · Tube tracheal w/wo connector
Curity: medical device reports filed with FDA
664 reports name it, 1998–2026. Manufacturer given most often on reports: Kendall Gammatron Thailand. Product code BTR.
- 664
- device reports naming the brand
- 0% of all MAUDE reports · about 23 a year
- 18
- reports, 12 months to August 2026
- 75 in the 12 months before
- 92%
- classified as malfunction
- 76.6% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 664 reports that name the brand "Curity" (tube tracheal w/wo connector), received between January 1998 and June 2026; the manufacturer given most often on reports is Kendall Gammatron Thailand. Spellings of one product vary from report to report.
18 reports arrived in the 12 months to August 2026, down 76% from 75 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 (92%), injury (7.5%) and death (0.2%); 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 gas/air leak (39.5%), inflation problem (11.3%) and material split, cut or torn (6%). The patient problems coded most often are unintended extubation, extubate and low oxygen saturation. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 |
|---|---|---|---|
| Gas/air leak | 262 | 39.5% | 16% |
| Inflation problem | 75 | 11.3% | 11.5% |
| Material split, cut or torn | 40 | 6% | 3.4% |
| Loose or intermittent connection | 21 | 3.2% | 0.7% |
| Leak/splashthe device leaked | 17 | 2.6% | 7% |
| Defective component | 15 | 2.3% | 2.8% |
| Air leak | 11 | 1.7% | 5.4% |
| Connection problema connection problem | 10 | 1.5% | 1.8% |
| Disconnection | 9 | 1.4% | 3.9% |
| Human-device interface problem | 8 | 1.2% | 0.5% |
| Insufficient device problem information | 8 | 1.2% | 0.9% |
| Material separation | 5 | 0.8% | 1.1% |
| Obstruction of flow | 5 | 0.8% | 0.9% |
| Contamination | 3 | 0.5% | 0.2% |
| Incomplete or missing packaging | 3 | 0.5% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 3 | 0.5% | 0.2% |
| Contamination /decontamination problem | 2 | 0.3% | 0.4% |
| Deflation problem | 2 | 0.3% | 4% |
| Device damaged prior to usethe device was damaged before use | 2 | 0.3% | 0.3% |
| Inadequacy of device shape and/or size | 2 | 0.3% | 0.4% |
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 |
|---|---|---|
| Unintended extubation | 212 | 31.9% |
| Extubate | 162 | 24.4% |
| Low oxygen saturation | 42 | 6.3% |
| Hypoventilation | 34 | 5.1% |
| No patient involvement | 33 | 5% |
| Hypoxialow oxygen | 15 | 2.3% |
| Dyspneashortness of breath | 10 | 1.5% |
| Injurya physical injury | 8 | 1.2% |
| Pulmonary emphysema | 4 | 0.6% |
| Cardiac arrestthe heart stopped | 3 | 0.5% |
| Respiratory distressdifficulty breathing | 3 | 0.5% |
| Wound infectionan infected wound | 3 | 0.5% |
| Respiratory arrestbreathing stopped | 2 | 0.3% |
| Tachycardiafast heart rate | 2 | 0.3% |
| Anxietyanxiety | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Curity | Product code BTR | All MAUDE reports |
|---|---|---|---|
| Reports | 664 | 19,171 | 26,136,888 |
| Share of that pool | — | 3.5% | 0% |
| Classified as death, per 1,000 reports | 2 | 13 | 9 |
| Classified as injury | 7.5% | 19.9% | 36.2% |
| Classified as malfunction | 92% | 76.6% | 62.3% |
| Filed by the manufacturer | 97.3% | 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% |
| 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% |
| Endotracheal Tubes - Airway Management | 203 | 0 | 0% |
| 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 Curity reports
How many FDA reports name Curity?
664 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 18 in the latest 12 months.
What kinds of events are reported?
malfunction (92%), injury (7.5%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
gas/air leak (39.5%), inflation problem (11.3%), material split, cut or torn (6%), loose or intermittent connection (3.2%) and leak/splash (2.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.3%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Curity 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.