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2026 data FDA MAUDE openFDA FDA Class I

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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 §878.4680 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Apparatus LIGHT-BOOK · MAUDE

#333 of 1000 · 4,706 reports · 1992–2026

  • BOOK 4,706 reports
  • RANK #333 of 1000
  • DEATH 13 death-typed
  • INJ 1,607 injury-typed
  • MALF 2,871 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 260
  • PHOTO System

Nearest event-volume peer: System, Nuclear Magnetic Resonance Imaging (7 report gap)

Apparatus, Suction, Single Patient Use, Portable, Nonpowered sits #333 of 1000 among tracked device types with 4,706 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 run above the device-type norm

Apparatus carries 34.1% INJURY-coded reports, 3.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 34.1% corpus 30.3% · above corpus mean (+3.9 pp)
  • MALF 61.0% corpus 64.8% · below corpus mean (-3.8 pp)

Lead product-problem code Break is 29% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 40% of manufacturer-tagged reports · Top event location HOSPITAL is 43% of location-tagged rows .

Apparatus in the event-volume neighbourhood

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

reports

What this shows Apparatus, Suction, Single Patient Use, Portable, Nonpowered carries 4,706 MAUDE reports, ranked #333 of 1000.

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

Event Types

Malfunction 2,871 (61.0%)
Injury 1,607 (34.1%)
Other 160 (3.4%)
55 (1.2%)
Death 13 (0.3%)

Patient Outcomes

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

2,137 (42.8%)
Required Intervention 1,321 (26.5%)
Other 928 (18.6%)
Hospitalization 261 (5.2%)
R 218 (4.4%)
O 40 (0.8%)
Disability 24 (0.5%)
S 15 (0.3%)
Death 14 (0.3%)
Life Threatening 12 (0.2%)
L 7 (0.1%)
Invalid Data 6 (0.1%)
H 5 (0.1%)

Top Product Problems

Break 1,480
Difficult to Remove 659
Disconnection 300
Suction Problem 277
Explanted 237
Tears, rips, holes in device, device material 223
Detachment Of Device Component 210
Device, or device fragments remain in patient 187
Air Leak 178
Other (for use when an appropriate device code cannot be identified) 173
Material Separation 172
Replace 154
Device, removal of (non-implant) 150
Inflation Problem 120
Device Contamination with Chemical or Other Material 117
Dull, Blunt 113
Material Fragmentation 110
Fracture 107
Suction Failure 103
Unknown (for use when the device problem is not known) 95

Yearly Trend

92
1992: 4
93
1993: 12
94
1994: 37
95
1995: 58
96
1996: 104
97
1997: 168
98
1998: 160
99
1999: 115
00
2000: 108
01
2001: 107
02
2002: 166
03
2003: 194
04
2004: 197
05
2005: 195
06
2006: 187
07
2007: 246
08
2008: 205
09
2009: 231
10
2010: 124
11
2011: 58
12
2012: 47
13
2013: 70
14
2014: 95
15
2015: 93
16
2016: 145
17
2017: 260
18
2018: 180
19
2019: 200
20
2020: 202
21
2021: 216
22
2022: 96
23
2023: 90
24
2024: 74
25
2025: 182
26
2026: 80

Reports rose to 182 in 2025, up from an average of 82 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 883
ETHICON, INC. 801
CARDINAL HEALTH 243
C.R. BARD INC. (COVINGTON) -1018233 196
BAXTER HEALTHCARE - CLEVELAND 97

Event Locations

HOSPITAL 2,025 (43.0%)
1,393 (29.6%)
I 1,042 (22.1%)
INVALID DATA 64 (1.4%)
NO INFORMATION 56 (1.2%)
UNKNOWN 36 (0.8%)
OTHER 35 (0.7%)
OUTPATIENT TREATMENT FACILITY 22 (0.5%)
HOME 17 (0.4%)
AMBULATORY SURGICAL FACILITY 7 (0.1%)
NURSING HOME 3 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.1%)
NOT APPLICABLE 2 (0.0%)
PATIENT'S ROOM OR WARD 1 (0.0%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs ETHICON, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Apparatus: 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 (4,706 here).

System, Nuclear Magnetic Resonance Imaging 4,713 Closed Antineoplastic And Hazardous Drug Re… 4,732 Staple, Removable 4,743 Table, Obstetrical, Ac-Powered 4,666

Similar death-typed counts

Nearest other device types by death-typed report count (13 here), distinct from the volume row.

Bariatric Bed 13 Chair, With Casters 13 Continuous Measurement Thermometer 13 Immunoassay Method, Troponin Subunit 13

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

Disclaimer: MAUDE figures for Apparatus 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 Apparatus; 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.