2026 data FDA MAUDE openFDA

Tube Tracheostomy And Tube Cuff

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 MAUDE casebook

openFDA event book Tube Tracheostomy And Tube Cuff MID-BOOK · MAUDE

#172 of 1000 · 14,497 reports · 1992–2026

  • BOOK 14,497 reports
  • RANK #172 of 1000
  • DEATH 161 death-typed
  • INJ 5,152 injury-typed
  • MALF 9,135 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 1,632
  • PHOTO Laparoscope

Nearest event-volume peer: Laparoscope, Gynecologic (And Accessories) (84 report gap)

Tube Tracheostomy And Tube Cuff sits #172 of 1000 among tracked device types with 14,497 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 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 35.5% corpus 30.4% · above corpus mean (+5.1 pp)
  • MALF 63.0% corpus 64.5% · below corpus mean (-1.5 pp)

Lead product-problem code Gas/Air Leak is 16% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 51% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Tube Tracheostomy And Tube Cuff in the event-volume neighbourhood

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

reports

What this shows Tube Tracheostomy And Tube Cuff carries 14,497 MAUDE reports, ranked #172 of 1000.

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

Event Types

Malfunction 9,135 (63.0%)
Injury 5,152 (35.5%)
Death 161 (1.1%)
27 (0.2%)
Other 22 (0.2%)

Patient Outcomes

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

8,889 (59.2%)
Required Intervention 4,453 (29.7%)
Other 520 (3.5%)
R 398 (2.7%)
Life Threatening 319 (2.1%)
Death 156 (1.0%)
Hospitalization 99 (0.7%)
L 64 (0.4%)
O 53 (0.4%)
H 20 (0.1%)
S 13 (0.1%)
Disability 13 (0.1%)
Congenital Anomaly 11 (0.1%)
D 6 (0.0%)

Top Product Problems

Gas/Air Leak 1,433
Use of Device Problem 1,365
Inflation Problem 1,345
Leak/Splash 891
Material Split, Cut or Torn 579
Defective Component 473
Break 472
Disconnection 309
Connection Problem 262
Crack 211
Fluid/Blood Leak 198
Material Separation 173
Defective Device 151
Material Puncture/Hole 151
Fracture 147
Material Integrity Problem 142
Appropriate Term/Code Not Available 125
Detachment of Device or Device Component 125
Deflation Problem 122
Human-Device Interface Problem 121

Yearly Trend

92
1992: 2
93
1993: 1
96
1996: 7
97
1997: 29
98
1998: 8
99
1999: 22
00
2000: 35
01
2001: 54
02
2002: 70
03
2003: 25
04
2004: 41
05
2005: 30
06
2006: 37
07
2007: 167
08
2008: 102
09
2009: 195
10
2010: 1,270
11
2011: 587
12
2012: 500
13
2013: 544
14
2014: 506
15
2015: 508
16
2016: 572
17
2017: 441
18
2018: 812
19
2019: 1,019
20
2020: 791
21
2021: 1,041
22
2022: 1,632
23
2023: 1,233
24
2024: 1,103
25
2025: 998
26
2026: 115

Related Entities for Tube Tracheostomy And Tube Cuff

Event Locations

8,287 (57.2%)
I 4,418 (30.5%)
HOSPITAL 1,201 (8.3%)
HOME 464 (3.2%)
NO INFORMATION 66 (0.5%)
INVALID DATA 27 (0.2%)
OTHER 24 (0.2%)
NURSING HOME 8 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare SMITHS MEDICAL ASD, INC. vs MMJ SA DE CV (USD) →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Tube Tracheostomy And Tube Cuff, 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 (14,497 here).

Similar death-typed counts

Nearest other device types by death-typed report count (161 here), distinct from the volume row.

Disclaimer: MAUDE figures for Tube Tracheostomy And Tube Cuff 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 And Tube Cuff; 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.