2026 data FDA MAUDE openFDA FDA Class I

Catheters, Suction, Tracheobronchial

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §868.6810 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Catheters, Suction, Tracheobronchial LIGHT-BOOK · MAUDE

#375 of 1000 · 3,457 reports · 1992–2026

  • BOOK 3,457 reports
  • RANK #375 of 1000
  • DEATH 42 death-typed
  • INJ 350 injury-typed
  • MALF 2,935 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 721
  • PHOTO Control

Nearest event-volume peer: Control, Pump Speed, Cardiopulmonary Bypass (12 report gap)

Catheters, Suction, Tracheobronchial sits #375 of 1000 among tracked device types with 3,457 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 sit below the device-type norm

Catheters, Suction, Tracheobronchial carries 10.1% INJURY-coded reports, 20.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 10.1% corpus 30.3% · below corpus mean (-20.2 pp)
  • MALF 84.9% corpus 64.8% · above corpus mean (+20.1 pp)

Lead product-problem code Disconnection is 28% of coded problems · Lead manufacturer AVANOS MEDICAL INC. accounts for 85% of manufacturer-tagged reports · Top event location I is 48% of location-tagged rows .

Catheters, Suction, Tracheobronchial in the event-volume neighbourhood

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

reports

What this shows Catheters, Suction, Tracheobronchial carries 3,457 MAUDE reports, ranked #375 of 1000.

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

Event Types

Malfunction 2,935 (84.9%)
Injury 350 (10.1%)
Other 98 (2.8%)
Death 42 (1.2%)
32 (0.9%)

Patient Outcomes

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

2,876 (81.7%)
Other 250 (7.1%)
Required Intervention 226 (6.4%)
Death 39 (1.1%)
R 33 (0.9%)
Life Threatening 29 (0.8%)
Hospitalization 25 (0.7%)
O 22 (0.6%)
L 11 (0.3%)
Disability 5 (0.1%)
H 2 (0.1%)
D 1 (0.0%)
S 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Disconnection 861
Break 393
Device Operates Differently Than Expected 308
Suction Problem 199
Gas/Air Leak 164
Suction Failure 158
Nonstandard Device 120
Detachment Of Device Component 118
Material Separation 99
Material Integrity Problem 93
Air Leak 91
Leak/Splash 91
Use of Device Problem 74
Detachment of Device or Device Component 64
Sticking 64
Material Split, Cut or Torn 49
Fitting Problem 44
Loose or Intermittent Connection 39
Difficult to Remove 38
Crack 34

Yearly Trend

92
1992: 3
93
1993: 3
94
1994: 21
95
1995: 9
96
1996: 15
97
1997: 25
98
1998: 28
99
1999: 22
00
2000: 16
01
2001: 28
02
2002: 94
03
2003: 47
04
2004: 38
05
2005: 42
06
2006: 37
07
2007: 31
08
2008: 17
09
2009: 37
10
2010: 20
11
2011: 42
12
2012: 54
13
2013: 48
14
2014: 65
15
2015: 295
16
2016: 316
17
2017: 113
18
2018: 721
19
2019: 121
20
2020: 149
21
2021: 63
22
2022: 309
23
2023: 198
24
2024: 210
25
2025: 164
26
2026: 56

Reports in 2025 (164) held close to the prior two-year average of 204.

Related Entities for Catheters, Suction, Tracheobronchial

Event Locations

I 1,646 (47.6%)
1,477 (42.7%)
HOSPITAL 257 (7.4%)
NO INFORMATION 43 (1.2%)
INVALID DATA 10 (0.3%)
HOME 9 (0.3%)
UNKNOWN 7 (0.2%)
NURSING HOME 4 (0.1%)
OTHER 4 (0.1%)

Compare AVANOS MEDICAL INC. vs COVIDIEN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheters, Suction, Tracheobronchial: 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 (3,457 here).

Similar death-typed counts

Nearest other device types by death-typed report count (42 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheters, Suction, Tracheobronchial 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 Catheters, Suction, Tracheobronchial; 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.