2026 data FDA MAUDE openFDA FDA Class II

Container, I.V.

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 §880.5025 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Container, I.V. LIGHT-BOOK · MAUDE

#274 of 1000 · 6,755 reports · 1992–2026

  • BOOK 6,755 reports
  • RANK #274 of 1000
  • DEATH 8 death-typed
  • INJ 80 injury-typed
  • MALF 6,533 malfunction
  • SPAN 1992–2026
  • PEAK 2012: 1,229
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal (25 report gap)

Container, I.V. sits #274 of 1000 among tracked device types with 6,755 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 →

Malfunction reports run above the device-type norm

Container, I.V. carries 96.7% MALFUNCTION-coded reports, 31.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 1.2% corpus 30.3% · below corpus mean (-29.1 pp)
  • MALF 96.7% corpus 64.8% · above corpus mean (+31.9 pp)

Lead product-problem code Device Contamination with Chemical or Other Material is 40% of coded problems · Lead manufacturer BAXTER HEALTHCARE - AIBONITO accounts for 49% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Container, I.V. in the event-volume neighbourhood

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

reports

What this shows Container, I.V. carries 6,755 MAUDE reports, ranked #274 of 1000.

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

Event Types

Malfunction 6,533 (96.7%)
98 (1.5%)
Injury 80 (1.2%)
Other 36 (0.5%)
Death 8 (0.1%)

Patient Outcomes

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

6,440 (95.2%)
Other 225 (3.3%)
Required Intervention 47 (0.7%)
Hospitalization 12 (0.2%)
Death 10 (0.1%)
R 9 (0.1%)
Disability 8 (0.1%)
Life Threatening 6 (0.1%)
L 3 (0.0%)
O 2 (0.0%)
S 2 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Device Contamination with Chemical or Other Material 2,600
Fluid/Blood Leak 1,376
Leak/Splash 607
Particulates 435
Contamination /Decontamination Problem 332
Break 156
Hole In Material 149
Disconnection 107
Material Separation 99
Foreign material 82
Defective Device 74
Detachment of Device or Device Component 60
Detachment Of Device Component 56
Misassembled 56
Crack 47
Tears, rips, holes in device, device material 46
Device Operates Differently Than Expected 44
Failure to Disconnect 42
Contamination 37
Suction Problem 36

Yearly Trend

92
1992: 11
93
1993: 5
94
1994: 64
95
1995: 46
96
1996: 44
97
1997: 26
98
1998: 35
99
1999: 30
00
2000: 32
01
2001: 48
02
2002: 42
03
2003: 27
04
2004: 37
05
2005: 48
06
2006: 35
07
2007: 43
08
2008: 22
09
2009: 38
10
2010: 87
11
2011: 797
12
2012: 1,229
13
2013: 622
14
2014: 575
15
2015: 543
16
2016: 527
17
2017: 284
18
2018: 142
19
2019: 205
20
2020: 147
21
2021: 162
22
2022: 112
23
2023: 127
24
2024: 158
25
2025: 225
26
2026: 180

Reports rose to 225 in 2025, up from an average of 143 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Container, I.V.

Event Locations

4,401 (65.2%)
I 1,600 (23.7%)
HOSPITAL 363 (5.4%)
NO INFORMATION 109 (1.6%)
UNKNOWN 83 (1.2%)
OTHER 77 (1.1%)
HOME 58 (0.9%)
OUTPATIENT TREATMENT FACILITY 34 (0.5%)
INVALID DATA 22 (0.3%)
AMBULATORY SURGICAL FACILITY 4 (0.1%)
NURSING HOME 2 (0.0%)
HOSPICE 1 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare BAXTER HEALTHCARE - AIBONITO vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Container, I.V.: 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 (6,755 here).

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Disclaimer: MAUDE figures for Container, I.V. 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 Container, I.V.; 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.