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Circuit, Breathing (W Connector, Adaptor, Y Piece)

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Circuit, Breathing (W Connector, Adaptor, Y Piece)

The FDA MAUDE database aggregates 2,298 adverse-event reports for Circuit, Breathing (W Connector, Adaptor, Y Piece) spanning the period from 1992 through 2026. Of these, 11 are classified as death reports, 296 as injury reports, and 1,867 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 13 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 336 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 251 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 9 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.

2,298
Total Reports
11
Death Reports
296
Injury Reports
1,867
Malfunctions

Event Types

Malfunction 1,867 (81.2%)
Injury 296 (12.9%)
Other 108 (4.7%)
16 (0.7%)
Death 11 (0.5%)

Patient Outcomes

1,761 (75.2%)
Other 270 (11.5%)
Required Intervention 199 (8.5%)
Life Threatening 35 (1.5%)
R 28 (1.2%)
Hospitalization 13 (0.6%)
Death 10 (0.4%)
Disability 9 (0.4%)
L 6 (0.3%)
O 5 (0.2%)
S 4 (0.2%)
Congenital Anomaly 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Gas/Air Leak 336
Leak/Splash 260
Disconnection 167
Product Quality Problem 105
Crack 94
Loose or Intermittent Connection 71
Material Puncture/Hole 54
Break 51
Connection Problem 36
Component Missing 24
Defective Component 24
Material Deformation 22
Detachment of Device or Device Component 21
Fracture 20
Obstruction of Flow 20
Fluid/Blood Leak 19
Fitting Problem 18
Material Split, Cut or Torn 18
Material Integrity Problem 17
Failure to Deliver 15

Yearly Trend

92
1992: 3
93
1993: 5
94
1994: 8
95
1995: 11
96
1996: 30
97
1997: 73
98
1998: 54
99
1999: 37
00
2000: 29
01
2001: 25
02
2002: 32
03
2003: 7
04
2004: 9
05
2005: 16
06
2006: 18
07
2007: 12
08
2008: 29
09
2009: 15
10
2010: 73
11
2011: 133
12
2012: 125
13
2013: 94
14
2014: 62
15
2015: 32
16
2016: 164
17
2017: 154
18
2018: 39
19
2019: 62
20
2020: 71
21
2021: 138
22
2022: 244
23
2023: 251
24
2024: 118
25
2025: 108
26
2026: 17

Related Entities for Circuit, Breathing (W Connector, Adaptor, Y Piece)

Event Locations

1,381 (60.1%)
I 530 (23.1%)
HOSPITAL 310 (13.5%)
OTHER 25 (1.1%)
INVALID DATA 17 (0.7%)
NO INFORMATION 16 (0.7%)
UNKNOWN 13 (0.6%)
AMBULATORY SURGICAL FACILITY 5 (0.2%)
HOME 1 (0.0%)

Compare TELEFLEX MEDICAL vs SMITHS MEDICAL INTERNATIONAL, LTD. →

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.