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2026 data FDA MAUDE openFDA FDA Class II

Injector, Contrast Medium, Automatic

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 §870.1650 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Injector, Contrast Medium, Automatic LIGHT-BOOK · MAUDE

#846 of 1000 · 576 reports · 1992–2026

  • BOOK 576 reports
  • RANK #846 of 1000
  • DEATH 17 death-typed
  • INJ 248 injury-typed
  • MALF 256 malfunction
  • SPAN 1992–2026
  • PEAK 2008: 72
  • PHOTO Sealant, Dural

Nearest event-volume peer: Sealant, Dural (0 report gap)

Injector, Contrast Medium, Automatic sits #846 of 1000 among tracked device types with 576 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 → · Similar-volume device →

Malfunction reports sit below the device-type norm

Injector, Contrast Medium, Automatic carries 44.4% MALFUNCTION-coded reports, 20.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.0% corpus 1.5% · above corpus mean (+1.4 pp)
  • INJ 43.1% corpus 30.3% · above corpus mean (+12.8 pp)
  • MALF 44.4% corpus 64.8% · below corpus mean (-20.4 pp)

Lead product-problem code Insufficient Device Problem Information is 20% of coded problems · Top event location is 61% of location-tagged rows .

Injector, Contrast Medium, Automatic in the event-volume neighbourhood

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

reports

What this shows Injector, Contrast Medium, Automatic carries 576 MAUDE reports, ranked #846 of 1000.

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

Event Types

Malfunction 256 (44.4%)
Injury 248 (43.1%)
Other 38 (6.6%)
17 (3.0%)
Death 17 (3.0%)

Patient Outcomes

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

236 (38.3%)
Other 164 (26.6%)
Required Intervention 110 (17.9%)
Hospitalization 34 (5.5%)
R 18 (2.9%)
Death 18 (2.9%)
Life Threatening 10 (1.6%)
L 9 (1.5%)
H 5 (0.8%)
O 4 (0.6%)
S 2 (0.3%)
Invalid Data 2 (0.3%)
D 1 (0.2%)
Congenital Anomaly 1 (0.2%)
Disability 1 (0.2%)
Not Applicable 1 (0.2%)

Top Product Problems

Insufficient Device Problem Information 85
Unknown (for use when the device problem is not known) 66
Adverse Event Without Identified Device or Use Problem 41
Break 29
Air Leak 25
Device Operates Differently Than Expected 22
Component Falling 16
False Negative Result 15
Improper or Incorrect Procedure or Method 15
Air/Gas in Device 11
Detachment Of Device Component 11
Self-Activation or Keying 11
Use of Device Problem 11
Device Issue 10
Fluid/Blood Leak 10
Component(s), broken 9
Excess Flow or Over-Infusion 9
Improper Flow or Infusion 9
Other (for use when an appropriate device code cannot be identified) 9
Leak/Splash 8

Yearly Trend

92
1992: 1
93
1993: 3
94
1994: 8
95
1995: 5
96
1996: 28
97
1997: 47
98
1998: 15
99
1999: 7
00
2000: 8
01
2001: 1
02
2002: 2
03
2003: 2
04
2004: 7
05
2005: 3
06
2006: 4
07
2007: 14
08
2008: 72
09
2009: 48
10
2010: 42
11
2011: 41
12
2012: 23
13
2013: 23
14
2014: 14
15
2015: 5
16
2016: 7
17
2017: 3
18
2018: 8
19
2019: 9
20
2020: 13
21
2021: 14
22
2022: 24
23
2023: 16
24
2024: 23
25
2025: 21
26
2026: 14

Reports in 2025 (21) held close to the prior two-year average of 20.

Related Entities for Injector, Contrast Medium, Automatic

Event Locations

353 (61.3%)
HOSPITAL 118 (20.5%)
I 41 (7.1%)
INVALID DATA 26 (4.5%)
NOT APPLICABLE 18 (3.1%)
OTHER 7 (1.2%)
OUTPATIENT DIAGNOSTIC FACILITY 6 (1.0%)
NO INFORMATION 5 (0.9%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)
UNKNOWN 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Injector, Contrast Medium, Automatic: 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 (576 here).

Sealant, Dural 576 Lead, Atomic Absorption 575 Pessary, Vaginal 575 Drug-Eluting Percutaneous Transluminal Coro… 578

Similar death-typed counts

Nearest other device types by death-typed report count (17 here), distinct from the volume row.

Accessories, Blood Circuit, Hemodialysis 17 Cable, Transducer And Electrode, Patient, 17 Cardiovascular Procedure Kit 17 Counter, Differential Cell 17

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

Disclaimer: MAUDE figures for Injector, Contrast Medium, Automatic 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 Injector, Contrast Medium, Automatic; 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.