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2026 data FDA MAUDE openFDA FDA Class II

Filter, Bacterial, Breathing-Circuit

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 §868.5260 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Filter, Bacterial, Breathing-Circuit LIGHT-BOOK · MAUDE

#663 of 1000 · 1,004 reports · 1992–2026

  • BOOK 1,004 reports
  • RANK #663 of 1000
  • DEATH 41 death-typed
  • INJ 191 injury-typed
  • MALF 733 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 98
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous (0 report gap)

Filter, Bacterial, Breathing-Circuit sits #663 of 1000 among tracked device types with 1,004 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

Filter, Bacterial, Breathing-Circuit carries 19.0% INJURY-coded reports, 11.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.1% corpus 1.5% · above corpus mean (+2.6 pp)
  • INJ 19.0% corpus 30.3% · below corpus mean (-11.3 pp)
  • MALF 73.0% corpus 64.8% · above corpus mean (+8.2 pp)

Lead product-problem code Partial Blockage is 11% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 70% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Filter, Bacterial, Breathing-Circuit in the event-volume neighbourhood

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

reports

What this shows Filter, Bacterial, Breathing-Circuit carries 1,004 MAUDE reports, ranked #663 of 1000.

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

Event Types

Malfunction 733 (73.0%)
Injury 191 (19.0%)
Death 41 (4.1%)
Other 33 (3.3%)
6 (0.6%)

Patient Outcomes

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

706 (67.7%)
Required Intervention 142 (13.6%)
Other 59 (5.7%)
Death 39 (3.7%)
Life Threatening 39 (3.7%)
R 30 (2.9%)
L 9 (0.9%)
Hospitalization 8 (0.8%)
H 5 (0.5%)
Disability 3 (0.3%)
O 2 (0.2%)
S 1 (0.1%)

Top Product Problems

Partial Blockage 93
Gas/Air Leak 68
Leak/Splash 56
Obstruction of Flow 55
Crack 50
Replace 47
Increase in Pressure 45
Device Operates Differently Than Expected 44
Break 42
Occlusion Within Device 38
Use of Device Problem 36
Material Separation 34
Tear, Rip or Hole in Device Packaging 33
Material Split, Cut or Torn 29
Disconnection 28
Device Displays Incorrect Message 25
Restricted Flow rate 25
Complete Blockage 24
Detachment Of Device Component 24
Detachment of Device or Device Component 24

Yearly Trend

92
1992: 2
94
1994: 3
95
1995: 3
96
1996: 4
97
1997: 24
98
1998: 14
99
1999: 16
00
2000: 16
01
2001: 14
02
2002: 13
03
2003: 7
04
2004: 30
05
2005: 10
06
2006: 17
07
2007: 32
08
2008: 27
09
2009: 18
10
2010: 40
11
2011: 9
12
2012: 16
13
2013: 47
14
2014: 98
15
2015: 51
16
2016: 34
17
2017: 29
18
2018: 33
19
2019: 30
20
2020: 33
21
2021: 56
22
2022: 67
23
2023: 40
24
2024: 51
25
2025: 79
26
2026: 41

Reports rose to 79 in 2025, up from an average of 46 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Filter, Bacterial, Breathing-Circuit

Top Manufacturers

TELEFLEX MEDICAL 229
MAQUET CRITICAL CARE AB 41
COVIDIEN 35
FISHER & PAYKEL HEALTHCARE LTD 24

Event Locations

563 (56.1%)
HOSPITAL 244 (24.3%)
I 176 (17.5%)
NO INFORMATION 9 (0.9%)
OTHER 3 (0.3%)
OUTPATIENT TREATMENT FACILITY 3 (0.3%)
INVALID DATA 2 (0.2%)
UNKNOWN 2 (0.2%)
NOT APPLICABLE 1 (0.1%)
NURSING HOME 1 (0.1%)

Compare TELEFLEX MEDICAL vs MAQUET CRITICAL CARE AB →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Filter, Bacterial, Breathing-Circuit: 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 (1,004 here).

Prosthesis 1,004 Mouthguard, Over-The-Counter 1,006 Electrode, Ion Specific, Potassium 1,008 Mixer, Cement, For Clinical Use 998

Similar death-typed counts

Nearest other device types by death-typed report count (41 here), distinct from the volume row.

Hysteroscope 41 Source, Brachytherapy, Radionuclide 41 Stimulator 41 Suture, Surgical, Absorbable, Polydioxanone 41

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Filter, Bacterial, Breathing-Circuit 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 Filter, Bacterial, Breathing-Circuit; 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.