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Tube, Tracheal (W/Wo Connector)

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Tube, Tracheal (W/Wo Connector)

The FDA MAUDE database aggregates 18,473 adverse-event reports for Tube, Tracheal (W/Wo Connector) spanning the period from 1992 through 2026. Of these, 254 are classified as death reports, 3,737 as injury reports, and 14,076 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 15 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Gas/Air Leak topping the list at 2,847 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 1,813 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 12 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

18,473
Total Reports
254
Death Reports
3,737
Injury Reports
14,076
Malfunctions

Event Types

Malfunction 14,076 (76.2%)
Injury 3,737 (20.2%)
Other 347 (1.9%)
Death 254 (1.4%)
59 (0.3%)

Patient Outcomes

13,281 (70.1%)
Required Intervention 3,341 (17.6%)
Other 986 (5.2%)
R 381 (2.0%)
Life Threatening 365 (1.9%)
Death 248 (1.3%)
Hospitalization 103 (0.5%)
O 88 (0.5%)
L 85 (0.4%)
H 24 (0.1%)
Disability 14 (0.1%)
D 13 (0.1%)
S 13 (0.1%)
Congenital Anomaly 7 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Gas/Air Leak 2,847
Use of Device Problem 2,350
Inflation Problem 1,455
Leak/Splash 784
Material Split, Cut or Torn 620
Disconnection 596
Defective Component 508
Deflation Problem 302
Connection Problem 290
Detachment of Device or Device Component 274
Air Leak 190
Material Puncture/Hole 174
Break 170
Material Integrity Problem 155
Device Markings/Labelling Problem 153
Material Rupture 133
Insufficient Information 128
Obstruction of Flow 127
Material Twisted/Bent 126
Material Separation 120

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: 1,813
26
2026: 339

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

Event Locations

10,232 (55.4%)
I 6,517 (35.3%)
HOSPITAL 1,447 (7.8%)
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%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.