2026 data FDA MAUDE openFDA FDA Class II

Tube, Tracheal (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 §868.5730 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Tube, Tracheal MID-BOOK · MAUDE

#147 of 1000 · 19,095 reports · 1992–2026

  • BOOK 19,095 reports
  • RANK #147 of 1000
  • DEATH 256 death-typed
  • INJ 3,802 injury-typed
  • MALF 14,630 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,819
  • PHOTO Impactor

Nearest event-volume peer: Impactor (192 report gap)

Tube, Tracheal (W/Wo Connector) sits #147 of 1000 among tracked device types with 19,095 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 →

Malfunction reports run above the device-type norm

Tube, Tracheal carries 76.6% MALFUNCTION-coded reports, 11.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 19.9% corpus 30.3% · below corpus mean (-10.4 pp)
  • MALF 76.6% corpus 64.8% · above corpus mean (+11.8 pp)

Lead product-problem code Gas/Air Leak is 19% of coded problems · Lead manufacturer MMJ SA DE CV (USD) accounts for 47% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Tube, Tracheal in the event-volume neighbourhood

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

reports

What this shows Tube, Tracheal (W/Wo Connector) carries 19,095 MAUDE reports, ranked #147 of 1000.

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

Event Types

Malfunction 14,630 (76.6%)
Injury 3,802 (19.9%)
Other 348 (1.8%)
Death 256 (1.3%)
59 (0.3%)

Patient Outcomes

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

13,866 (70.6%)
Required Intervention 3,377 (17.2%)
Other 1,027 (5.2%)
R 395 (2.0%)
Life Threatening 370 (1.9%)
Death 249 (1.3%)
Hospitalization 110 (0.6%)
O 94 (0.5%)
L 87 (0.4%)
H 24 (0.1%)
Disability 14 (0.1%)
S 13 (0.1%)
D 12 (0.1%)
Congenital Anomaly 7 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Gas/Air Leak 3,045
Use of Device Problem 2,573
Inflation Problem 2,198
Leak/Splash 1,336
Air Leak 1,038
Deflation Problem 761
Disconnection 748
Material Split, Cut or Torn 655
Defective Component 552
Break 409
Kinked 376
Device Contamination with Chemical or Other Material 354
Connection Problem 353
Replace 326
Detachment of Device or Device Component 312
Device Markings/Labelling Problem 307
Device Operates Differently Than Expected 250
Detachment Of Device Component 247
Material Separation 223
Material Integrity Problem 203

Yearly Trend

92
1992: 4
93
1993: 8
94
1994: 34
95
1995: 26
96
1996: 47
97
1997: 148
98
1998: 159
99
1999: 111
00
2000: 127
01
2001: 150
02
2002: 85
03
2003: 62
04
2004: 65
05
2005: 115
06
2006: 101
07
2007: 136
08
2008: 169
09
2009: 155
10
2010: 335
11
2011: 422
12
2012: 511
13
2013: 807
14
2014: 985
15
2015: 1,016
16
2016: 836
17
2017: 812
18
2018: 977
19
2019: 1,379
20
2020: 1,070
21
2021: 1,329
22
2022: 1,132
23
2023: 1,330
24
2024: 1,678
25
2025: 1,819
26
2026: 955

Reports in 2025 (1,819) held close to the prior two-year average of 1,504.

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

Top Manufacturers

Event Locations

10,848 (56.8%)
I 6,514 (34.1%)
HOSPITAL 1,456 (7.6%)
NO INFORMATION 119 (0.6%)
UNKNOWN 46 (0.2%)
INVALID DATA 32 (0.2%)
HOME 30 (0.2%)
NOT APPLICABLE 15 (0.1%)
OTHER 15 (0.1%)
AMBULATORY SURGICAL FACILITY 10 (0.1%)
OUTPATIENT TREATMENT FACILITY 7 (0.0%)
NURSING HOME 3 (0.0%)

Compare MMJ SA DE CV (USD) vs TELEFLEX MEDICAL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tube, Tracheal: 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 (19,095 here).

Similar death-typed counts

Nearest other device types by death-typed report count (256 here), distinct from the volume row.

Disclaimer: MAUDE figures for Tube, Tracheal 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, Tracheal; 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.