PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Tube, Tracheostomy (W/Wo Connector)

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §868.5800 (Anesthesiology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Tube, Tracheostomy LIGHT-BOOK · MAUDE

#278 of 1000 · 6,588 reports · 1992–2026

  • BOOK 6,588 reports
  • RANK #278 of 1000
  • DEATH 163 death-typed
  • INJ 2,174 injury-typed
  • MALF 4,139 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 795
  • PHOTO Separator

Nearest event-volume peer: Separator, Automated, Blood Cell, Diagnostic (13 report gap)

Tube, Tracheostomy (W/Wo Connector) sits #278 of 1000 among tracked device types with 6,588 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Tube, Tracheostomy carries 33.0% INJURY-coded reports, 2.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.5% corpus 1.5% · above corpus mean (+1.0 pp)
  • INJ 33.0% corpus 30.3% · above corpus mean (+2.7 pp)
  • MALF 62.8% corpus 64.8% · below corpus mean (-2.0 pp)

Lead product-problem code Air Leak is 15% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 84% of manufacturer-tagged reports · Top event location is 72% of location-tagged rows .

Tube, Tracheostomy in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Tube, Tracheostomy (W/Wo Connector) carries 6,588 MAUDE reports, ranked #278 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 4,139 (62.8%)
Injury 2,174 (33.0%)
Death 163 (2.5%)
Other 70 (1.1%)
42 (0.6%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

4,163 (61.7%)
Required Intervention 1,873 (27.7%)
Other 185 (2.7%)
Death 152 (2.3%)
R 119 (1.8%)
Life Threatening 112 (1.7%)
Hospitalization 71 (1.1%)
Disability 24 (0.4%)
L 19 (0.3%)
S 16 (0.2%)
O 9 (0.1%)
H 5 (0.1%)
D 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Air Leak 900
Replace 808
Leak/Splash 640
Inflation Problem 565
Break 452
Gas/Air Leak 441
Device, removal of (non-implant) 319
Material Separation 270
Crack 255
Detachment Of Device Component 166
Disconnection 162
Difficult to Insert 143
Deflation Problem 139
Detachment of Device or Device Component 136
Component(s), broken 127
Fitting Problem 116
Inadequacy of Device Shape and/or Size 104
Defective Component 99
Fracture 94
Use of Device Problem 91

Yearly Trend

92
1992: 5
93
1993: 9
94
1994: 8
95
1995: 30
96
1996: 110
97
1997: 193
98
1998: 169
99
1999: 242
00
2000: 181
01
2001: 139
02
2002: 98
03
2003: 45
04
2004: 75
05
2005: 227
06
2006: 229
07
2007: 226
08
2008: 255
09
2009: 795
10
2010: 130
11
2011: 54
12
2012: 82
13
2013: 78
14
2014: 173
15
2015: 172
16
2016: 212
17
2017: 126
18
2018: 162
19
2019: 87
20
2020: 113
21
2021: 198
22
2022: 770
23
2023: 402
24
2024: 418
25
2025: 238
26
2026: 137

Reports fell to 238 in 2025, down from an average of 410 in the two years before.

Related Entities for Tube, Tracheostomy (W/Wo Connector)

Top Manufacturers

SMITHS MEDICAL ASD, INC. 648
COVIDIEN 128

Event Locations

4,746 (72.0%)
I 803 (12.2%)
HOSPITAL 702 (10.7%)
INVALID DATA 152 (2.3%)
HOME 106 (1.6%)
NO INFORMATION 31 (0.5%)
NURSING HOME 17 (0.3%)
OTHER 15 (0.2%)
UNKNOWN 9 (0.1%)
NOT APPLICABLE 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare SMITHS MEDICAL ASD, INC. vs COVIDIEN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tube, Tracheostomy: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (6,588 here).

Separator, Automated, Blood Cell, Diagnostic 6,575 Ureteroscope And Accessories, Flexible/Rigid 6,637 System, Imaging, Pulsed Echo, Ultrasonic 6,516 Hearing Aid, Bone Conduction, Implanted 6,678

Similar death-typed counts

Nearest other device types by death-typed report count (163 here), distinct from the volume row.

Tube Tracheostomy And Tube Cuff 164 Ventilator, Emergency, Manual 164 Dialyzer, Capillary, Hollow Fiber 157 Mattress 154

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Tube, Tracheostomy are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Tube, Tracheostomy; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.