Devices › Tube, tracheostomy (w/wo connector)
Device brand name · Tube tracheostomy w/wo connector
Portex Blue Line Ultra Tracheostomy Tube: medical device reports filed with FDA
287 reports name it, 2010–2026. Manufacturer given most often on reports: Smiths Medical Asd. Product code BTO.
- 287
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 30
- reports, 12 months to August 2026
- 7 in the 12 months before
- 69.7%
- classified as malfunction
- 62.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
287 medical device reports received by FDA name the brand "Portex Blue Line Ultra Tracheostomy Tube" (tube tracheostomy w/wo connector); the manufacturer given most often on reports is Smiths Medical Asd; received from July 2010 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
30 reports arrived in the 12 months to August 2026, up 329% from 7 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 (69.7%) and injury (30.3%); across all tube, tracheostomy (w/wo connector) reports (product code BTO) death is recorded in 2.5% and malfunction in 62.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (20.2%), inflation problem (13.6%) and gas/air leak (11.1%). The patient problems coded most often are low oxygen saturation, dyspnea and decreased respiratory rate. 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 6,603 reports carrying product code BTO. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 58 | 20.2% | 9.7% |
| Inflation problem | 39 | 13.6% | 8.6% |
| Gas/air leak | 32 | 11.1% | 6.8% |
| Contamination /decontamination problem | 23 | 8% | 0.7% |
| Crackthe device cracked | 14 | 4.9% | 3.9% |
| Breakthe device broke | 13 | 4.5% | 6.8% |
| Material puncture/hole | 11 | 3.8% | 1% |
| Component missing | 8 | 2.8% | 0.9% |
| Material split, cut or torn | 8 | 2.8% | 1% |
| Decrease in pressure | 5 | 1.7% | 0.9% |
| Deflation problem | 5 | 1.7% | 2.1% |
| Disconnection | 5 | 1.7% | 2.3% |
| Insufficient device problem information | 5 | 1.7% | 0.3% |
| Air leak | 4 | 1.4% | 13.6% |
| Complete blockage | 4 | 1.4% | 0.1% |
| Inadequacy of device shape and/or size | 4 | 1.4% | 1.5% |
| Fracturea broken bone | 3 | 1% | 1.3% |
| Incomplete or missing packaging | 3 | 1% | 0.3% |
| Material integrity problema problem with the device material | 3 | 1% | 0.4% |
| Material perforation | 3 | 1% | 0.2% |
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 |
|---|---|---|
| Low oxygen saturation | 8 | 2.8% |
| Dyspneashortness of breath | 6 | 2.1% |
| Decreased respiratory rate | 5 | 1.7% |
| Hypoxialow oxygen | 5 | 1.7% |
| Painpain, site not specified | 4 | 1.4% |
| Respiratory distressdifficulty breathing | 3 | 1% |
| Airway obstruction | 2 | 0.7% |
| Blood loss | 2 | 0.7% |
| Foreign body reaction | 2 | 0.7% |
| Hemoptysis | 2 | 0.7% |
| Anxietyanxiety | 1 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.3% |
| Bruise/contusion | 1 | 0.3% |
| Confusion/ disorientation | 1 | 0.3% |
| Discomfortdiscomfort | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Portex Blue Line Ultra Tracheostomy Tube | Product code BTO | All MAUDE reports |
|---|---|---|---|
| Reports | 287 | 6,603 | 26,136,888 |
| Share of that pool | — | 4.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 25 | 9 |
| Classified as injury | 30.3% | 32.9% | 36.2% |
| Classified as malfunction | 69.7% | 62.9% | 62.3% |
| Filed by the manufacturer | 99.7% | 91.8% | 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 BTO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Shiley | 12,236 | 1,513 | 1.1% |
| Portex | 970 | 8 | 0.6% |
| Portex Tubes BLUselect Suctionaid | 162 | 72 | 0.6% |
| Shiley Low Pressure Cuffed | 499 | 0 | 0.4% |
| Portex General Anesthesia Circuits | 363 | 10 | 0% |
| Shiley Disposable Cannula Low Pressure | 522 | 0 | 0.8% |
| Bivona | 768 | 11 | 1% |
| Bivona Tracheostomy Tube Neonatal/Pediatric | 232 | 7 | 0.9% |
| Shiley Fenestrated Low Pressure Cuffed | 198 | 0 | 0% |
| Mallinckrodt | 3,105 | 1 | 1.2% |
| Portex Endotracheal Tube | 281 | 25 | 0% |
| Portex Endotracheal Tubes | 223 | 36 | 0.4% |
| Fluency Plus Tracheobronchial Stent Graft | 323 | 0 | 0% |
| AirLife | 155 | 37 | 2.6% |
| Bivona Customized Tracheostomy Tubes | 200 | 24 | 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 Portex Blue Line Ultra Tracheostomy Tube reports
How many FDA reports name Portex Blue Line Ultra Tracheostomy Tube?
287 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 30 in the latest 12 months.
What kinds of events are reported?
malfunction (69.7%) and injury (30.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (20.2%), inflation problem (13.6%), gas/air leak (11.1%), contamination /decontamination problem (8%) and crack (4.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Portex Blue Line Ultra Tracheostomy Tube 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.