Devices › Tube tracheostomy and tube cuff
Device brand name · Tube tracheal w/wo connector
Shiley: medical device reports filed with FDA
12,236 reports name it, 1993–2026. Manufacturer given most often on reports: Mmj De Cv Usd. Product code JOH.
- 12,236
- device reports naming the brand
- 0% of all MAUDE reports · about 365 a year
- 1,513
- reports, 12 months to August 2026
- 1,714 in the 12 months before
- 74.5%
- classified as malfunction
- 63.9% across the product code
- 1.1%
- classified as death, as reported
- 132 reports · not verified by FDA
FDA's MAUDE database holds 12,236 reports that name the brand "Shiley" (tube tracheal w/wo connector), received between January 1993 and August 2026; the manufacturer given most often on reports is Mmj De Cv Usd. Spellings of one product vary from report to report.
1,513 reports arrived in the 12 months to August 2026, down 12% from 1,714 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 (74.5%), injury (24.3%) and death (1.1%); across all tube tracheostomy and tube cuff reports (product code JOH) death is recorded in 1.1% and malfunction in 63.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are gas/air leak (21.8%), material split, cut or torn (7.5%) and defective component (6.8%). The patient problems coded most often are unintended extubation, extubate and no patient involvement. 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 15,022 reports carrying product code JOH. 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 | 2,666 | 21.8% | 10.4% |
| Material split, cut or torn | 923 | 7.5% | 4.1% |
| Defective component | 833 | 6.8% | 3.4% |
| Disconnection | 543 | 4.4% | 2.4% |
| Leak/splashthe device leaked | 485 | 4% | 7.9% |
| Inflation problem | 443 | 3.6% | 12.4% |
| Connection problema connection problem | 391 | 3.2% | 2.1% |
| Air leak | 324 | 2.6% | 11.4% |
| Replace | 307 | 2.5% | 1.1% |
| Deflation problem | 261 | 2.1% | 1.6% |
| Crackthe device cracked | 240 | 2% | 1.9% |
| Material separation | 214 | 1.7% | 1.7% |
| Human-device interface problem | 211 | 1.7% | 0.9% |
| Breakthe device broke | 179 | 1.5% | 5.1% |
| Material integrity problema problem with the device material | 155 | 1.3% | 1.1% |
| Insufficient device problem information | 143 | 1.2% | 0.9% |
| Obstruction of flow | 110 | 0.9% | 0.8% |
| Labelling, instructions for use or training problem | 102 | 0.8% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 96 | 0.8% | 1.5% |
| Device, removal of (non-implant) | 83 | 0.7% | 0.7% |
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 | 3,557 | 29.1% |
| Extubate | 1,170 | 9.6% |
| No patient involvement | 890 | 7.3% |
| Low oxygen saturation | 263 | 2.1% |
| Hypoventilation | 217 | 1.8% |
| Reintubate | 94 | 0.8% |
| Hemorrhage/blood loss/bleeding | 88 | 0.7% |
| Dyspneashortness of breath | 87 | 0.7% |
| Deaththe patient died; cause not stated by this term | 75 | 0.6% |
| Cardiac arrestthe heart stopped | 74 | 0.6% |
| Discomfortdiscomfort | 64 | 0.5% |
| Injurya physical injury | 41 | 0.3% |
| Therapy/non-surgical treatment, additional | 41 | 0.3% |
| Aspiration/inhalation | 34 | 0.3% |
| Intubation | 31 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Shiley | Product code JOH | All MAUDE reports |
|---|---|---|---|
| Reports | 12,236 | 15,022 | 26,136,888 |
| Share of that pool | — | 81.5% | 0% |
| Classified as death, per 1,000 reports | 11 | 11 | 9 |
| Classified as injury | 24.3% | 34.6% | 36.2% |
| Classified as malfunction | 74.5% | 63.9% | 62.3% |
| Filed by the manufacturer | 97.9% | 95.5% | 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 JOH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bivona | 768 | 11 | 1% |
| Shiley Disposable Cannula Low Pressure | 522 | 0 | 0.8% |
| Shiley Low Pressure Cuffed | 499 | 0 | 0.4% |
| Bivona Customized Tracheostomy Tubes | 200 | 24 | 1% |
| Bivona Flextend Pediatric and Neonatal Trach Tube | 180 | 44 | 0% |
| Bivona Tracheostomy Tube Neonatal/Pediatric | 232 | 7 | 0.9% |
| Shiley Fenestrated Low Pressure Cuffed | 198 | 0 | 0% |
| Portex | 970 | 8 | 0.6% |
| Portex Blue Line Ultra Tracheostomy Tube | 287 | 30 | 0% |
| Mallinckrodt | 3,105 | 1 | 1.2% |
| Portex Endotracheal Tube | 281 | 25 | 0% |
| Kangaroo Joey Pump W/Pole Clmp | 571 | 0 | 0.4% |
| Scd 700 Compression System-Us | 169 | 0 | 0% |
| Flextend | 6,836 | 203 | 0.7% |
| Level 1 Hotline Low Flow System Hl-90 | 170 | 0 | 0% |
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 Shiley reports
How many FDA reports name Shiley?
12,236 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,513 in the latest 12 months.
What kinds of events are reported?
malfunction (74.5%), injury (24.3%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
gas/air leak (21.8%), material split, cut or torn (7.5%), defective component (6.8%), disconnection (4.4%) and leak/splash (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.9%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Shiley 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.