2026 data FDA MAUDE openFDA FDA Class II

Bottle, Collection, Vacuum

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 §880.6740 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Bottle, Collection, Vacuum LIGHT-BOOK · MAUDE

#481 of 1000 · 2,145 reports · 1992–2026

  • BOOK 2,145 reports
  • RANK #481 of 1000
  • DEATH 55 death-typed
  • INJ 442 injury-typed
  • MALF 1,484 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 172
  • PHOTO Catheter, Septostomy

Nearest event-volume peer: Catheter, Septostomy (1 report gap)

Bottle, Collection, Vacuum sits #481 of 1000 among tracked device types with 2,145 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

Bottle, Collection, Vacuum carries 20.6% INJURY-coded reports, 9.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.6% corpus 1.5% · above corpus mean (+1.1 pp)
  • INJ 20.6% corpus 30.3% · below corpus mean (-9.7 pp)
  • MALF 69.2% corpus 64.8% · above corpus mean (+4.4 pp)

Lead product-problem code Break is 12% of coded problems · Lead manufacturer ATRIUM MEDICAL CORPORATION accounts for 44% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Bottle, Collection, Vacuum in the event-volume neighbourhood

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

reports

What this shows Bottle, Collection, Vacuum carries 2,145 MAUDE reports, ranked #481 of 1000.

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

Event Types

Malfunction 1,484 (69.2%)
Injury 442 (20.6%)
Other 109 (5.1%)
55 (2.6%)
Death 55 (2.6%)

Patient Outcomes

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

1,366 (61.2%)
Required Intervention 346 (15.5%)
Other 294 (13.2%)
R 49 (2.2%)
Death 49 (2.2%)
Hospitalization 46 (2.1%)
Life Threatening 26 (1.2%)
L 18 (0.8%)
H 8 (0.4%)
O 7 (0.3%)
S 7 (0.3%)
Disability 6 (0.3%)
D 5 (0.2%)
Invalid Data 4 (0.2%)

Top Product Problems

Break 203
Suction Problem 188
Fluid/Blood Leak 173
Leak/Splash 116
Replace 112
Vacuum, loss of 106
Air Leak 91
Off-Label Use 89
Difficult to Remove 81
Crack 74
Use of Device Problem 73
Other (for use when an appropriate device code cannot be identified) 61
Material Separation 59
Device, or device fragments remain in patient 51
Burst Container or Vessel 47
Disconnection 47
Decrease in Suction 46
Device, removal of (non-implant) 44
Device Operates Differently Than Expected 42
Component(s), broken 41

Yearly Trend

92
1992: 1
93
1993: 5
94
1994: 22
95
1995: 29
96
1996: 52
97
1997: 104
98
1998: 83
99
1999: 59
00
2000: 52
01
2001: 30
02
2002: 35
03
2003: 32
04
2004: 56
05
2005: 54
06
2006: 50
07
2007: 48
08
2008: 67
09
2009: 165
10
2010: 50
11
2011: 40
12
2012: 22
13
2013: 44
14
2014: 43
15
2015: 34
16
2016: 77
17
2017: 53
18
2018: 45
19
2019: 57
20
2020: 110
21
2021: 110
22
2022: 118
23
2023: 92
24
2024: 172
25
2025: 95
26
2026: 39

Reports in 2025 (95) held close to the prior two-year average of 132.

Related Entities for Bottle, Collection, Vacuum

Event Locations

1,080 (50.3%)
HOSPITAL 577 (26.9%)
I 403 (18.8%)
INVALID DATA 27 (1.3%)
NO INFORMATION 13 (0.6%)
UNKNOWN 13 (0.6%)
OTHER 9 (0.4%)
AMBULATORY SURGICAL FACILITY 7 (0.3%)
HOME 6 (0.3%)
NOT APPLICABLE 5 (0.2%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)

Compare ATRIUM MEDICAL CORPORATION vs TELEFLEX MEDICAL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Bottle, Collection, Vacuum: 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 (2,145 here).

Similar death-typed counts

Nearest other device types by death-typed report count (55 here), distinct from the volume row.

Disclaimer: MAUDE figures for Bottle, Collection, Vacuum 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 Bottle, Collection, Vacuum; 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.