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Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

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

The FDA MAUDE database aggregates 1,558 adverse-event reports for Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) spanning the period from 1992 through 2026. Of these, 12 are classified as death reports, 168 as injury reports, and 1,335 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 12 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 Break topping the list at 217 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 34 years of MAUDE data, with the peak single-year volume reaching 159 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 7 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.

1,558
Total Reports
12
Death Reports
168
Injury Reports
1,335
Malfunctions

Event Types

Malfunction 1,335 (85.7%)
Injury 168 (10.8%)
Other 41 (2.6%)
Death 12 (0.8%)
2 (0.1%)

Patient Outcomes

1,259 (79.8%)
Other 147 (9.3%)
Required Intervention 118 (7.5%)
R 18 (1.1%)
Life Threatening 13 (0.8%)
Death 10 (0.6%)
O 4 (0.3%)
Hospitalization 3 (0.2%)
L 2 (0.1%)
D 1 (0.1%)
H 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 217
Leak/Splash 139
Inflation Problem 118
Gas/Air Leak 106
Deflation Problem 36
Crack 19
Material Rupture 16
Material Separation 14
Material Twisted/Bent 14
Fracture 13
Material Deformation 13
Mechanical Problem 13
Output Problem 13
Component Missing 12
Material Split, Cut or Torn 10
Structural Problem 10
Air Leak 8
Device Operates Differently Than Expected 8
Ejection Problem 7
Infusion or Flow Problem 7

Yearly Trend

92
1992: 2
93
1993: 1
95
1995: 2
96
1996: 32
97
1997: 77
98
1998: 33
99
1999: 27
00
2000: 66
01
2001: 99
02
2002: 78
03
2003: 22
04
2004: 29
05
2005: 13
06
2006: 8
07
2007: 11
08
2008: 16
09
2009: 26
10
2010: 25
11
2011: 20
12
2012: 23
13
2013: 26
14
2014: 18
15
2015: 8
16
2016: 29
17
2017: 61
18
2018: 66
19
2019: 94
20
2020: 87
21
2021: 159
22
2022: 127
23
2023: 95
24
2024: 75
25
2025: 85
26
2026: 18

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

Event Locations

625 (40.1%)
HOSPITAL 495 (31.8%)
I 412 (26.4%)
INVALID DATA 15 (1.0%)
UNKNOWN 7 (0.4%)
NOT APPLICABLE 2 (0.1%)
OTHER 2 (0.1%)

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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.