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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Tube, Tracheostomy LIGHT-BOOK · MAUDE

#274 of 1000 · 6,484 reports · 1992–2026

  • BOOK 6,484 reports
  • RANK #274 of 1000
  • DEATH 162 death-typed
  • INJ 2,164 injury-typed
  • MALF 4,046 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 795
  • PHOTO Transcatheter Septal…

Nearest event-volume peer: Transcatheter Septal Occluder (19 report gap)

Tube, Tracheostomy (W/Wo Connector) sits #274 of 1000 among tracked device types with 6,484 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 2.5% corpus 1.5% · above corpus mean (+1.0 pp)
  • INJ 33.4% corpus 30.4% · above corpus mean (+2.9 pp)
  • MALF 62.4% corpus 64.5% · below corpus mean (-2.1 pp)

Lead product-problem code Gas/Air Leak is 18% of coded problems · Lead manufacturer SMITHS MEDICAL INTERNATIONAL, LTD. accounts for 51% 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 6,484 MAUDE reports, ranked #274 of 1000.

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

Event Types

Malfunction 4,046 (62.4%)
Injury 2,164 (33.4%)
Death 162 (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.

4,070 (61.2%)
Required Intervention 1,864 (28.0%)
Other 185 (2.8%)
Death 151 (2.3%)
R 119 (1.8%)
Life Threatening 111 (1.7%)
Hospitalization 71 (1.1%)
Disability 24 (0.4%)
L 19 (0.3%)
S 16 (0.2%)
O 8 (0.1%)
H 5 (0.1%)
D 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Gas/Air Leak 401
Leak/Splash 302
Inflation Problem 243
Break 202
Detachment of Device or Device Component 128
Crack 126
Disconnection 103
Air Leak 87
Connection Problem 71
Material Split, Cut or Torn 64
Defective Component 63
Fluid/Blood Leak 59
Material Puncture/Hole 58
Fracture 56
Material Separation 55
Component Missing 47
Contamination /Decontamination Problem 47
Deflation Problem 45
Unintended Deflation 43
Decrease in Pressure 40

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: 33

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

Top Manufacturers

SMITHS MEDICAL INTERNATIONAL, LTD. 1,076
SMITHS MEDICAL ASD, INC. 646
SMITHS MEDICAL INTERNATIONAL LTD. 243
COVIDIEN 127

Event Locations

4,643 (71.6%)
I 803 (12.4%)
HOSPITAL 702 (10.8%)
INVALID DATA 152 (2.3%)
HOME 106 (1.6%)
NO INFORMATION 31 (0.5%)
NURSING HOME 17 (0.3%)
OTHER 14 (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 INTERNATIONAL, LTD. vs SMITHS MEDICAL ASD, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Tube, Tracheostomy, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (6,484 here).

Transcatheter Septal Occluder 6,503 Hearing Aid, Bone Conduction, Implanted 6,463 Separator, Automated, Blood Cell, Diagnostic 6,535 Continuous, Ventilator, Home Use 6,546

Similar death-typed counts

Nearest other device types by death-typed report count (162 here), distinct from the volume row.

Ventilator, Emergency, Manual 162 Tube Tracheostomy And Tube Cuff 161 Dilator 165 Dialyzer, Capillary, Hollow Fiber 157

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.