2025 data FDA MAUDE openFDA FDA Class II

Injector, Fluid, Non-Electrically Powered

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 §880.5430 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Injector, Fluid, Non-Electrically Powered LIGHT-BOOK · MAUDE

#919 of 1000 · 467 reports · 1992–2025

  • BOOK 467 reports
  • RANK #919 of 1000
  • DEATH 2 death-typed
  • INJ 151 injury-typed
  • MALF 139 malfunction
  • SPAN 1992–2025
  • PEAK 2001: 71
  • PHOTO Test

Nearest event-volume peer: Test, Natriuretic Peptide (0 report gap)

Injector, Fluid, Non-Electrically Powered sits #919 of 1000 among tracked device types with 467 MAUDE reports spanning 1992–2025. 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 sit below the device-type norm

Injector, Fluid, Non-Electrically Powered carries 29.8% MALFUNCTION-coded reports, 35.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 32.3% corpus 30.3% · above corpus mean (+2.0 pp)
  • MALF 29.8% corpus 64.8% · below corpus mean (-35.1 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 13% of coded problems · Lead manufacturer BECTON DICKINSON accounts for 100% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .

Injector, Fluid, Non-Electrically Powered in the event-volume neighbourhood

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

reports

What this shows Injector, Fluid, Non-Electrically Powered carries 467 MAUDE reports, ranked #919 of 1000.

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

Event Types

Injury 151 (32.3%)
Malfunction 139 (29.8%)
Other 112 (24.0%)
63 (13.5%)
Death 2 (0.4%)

Patient Outcomes

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

185 (36.1%)
Hospitalization 150 (29.2%)
Other 81 (15.8%)
Required Intervention 27 (5.3%)
R 26 (5.1%)
Life Threatening 21 (4.1%)
L 8 (1.6%)
O 8 (1.6%)
S 4 (0.8%)
Death 2 (0.4%)
Disability 1 (0.2%)

Top Product Problems

Unknown (for use when the device problem is not known) 73
Component(s), broken 57
Replace 54
Use of Device Problem 53
Failure to Deliver 40
Break 37
Sticking 37
Malfunction 26
Device Issue 23
Crack 19
Inaccurate Delivery 19
Other (for use when an appropriate device code cannot be identified) 18
Design/structure problem 16
Underdelivery 16
Fluid/Blood Leak 12
Defective Component 11
Defective Device 11
Leak/Splash 11
Adverse Event Without Identified Device or Use Problem 10
Overdelivery 10

Yearly Trend

92
1992: 1
93
1993: 1
95
1995: 1
96
1996: 10
97
1997: 22
98
1998: 18
99
1999: 18
00
2000: 10
01
2001: 71
02
2002: 69
03
2003: 30
04
2004: 24
05
2005: 35
06
2006: 50
07
2007: 54
08
2008: 5
09
2009: 8
10
2010: 9
11
2011: 7
12
2012: 6
13
2013: 4
14
2014: 10
19
2019: 1
22
2022: 1
24
2024: 1
25
2025: 1

Reports in 2024 (1) held close to the prior two-year average of 1.

Related Entities for Injector, Fluid, Non-Electrically Powered

Top Manufacturers

Event Locations

369 (79.0%)
HOME 38 (8.1%)
UNKNOWN 16 (3.4%)
INVALID DATA 13 (2.8%)
HOSPITAL 11 (2.4%)
I 11 (2.4%)
NOT APPLICABLE 3 (0.6%)
OTHER 3 (0.6%)
OUTPATIENT TREATMENT FACILITY 2 (0.4%)
NURSING HOME 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Injector, Fluid, Non-Electrically Powered: 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 (467 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Injector, Fluid, Non-Electrically Powered 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, Fluid, Non-Electrically Powered; 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.