2026 data FDA MAUDE openFDA

Injector, Pen

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 MAUDE casebook

openFDA event book Injector, Pen LIGHT-BOOK · MAUDE

#777 of 1000 · 665 reports · 2004–2026

  • BOOK 665 reports
  • RANK #777 of 1000
  • DEATH 1 death-typed
  • INJ 183 injury-typed
  • MALF 472 malfunction
  • SPAN 2004–2026
  • PEAK 2010: 105
  • PHOTO Enteroscope And Acces…

Nearest event-volume peer: Enteroscope And Accessories (0 report gap)

Injector, Pen sits #777 of 1000 among tracked device types with 665 MAUDE reports spanning 2004–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 27.5% corpus 30.4% · below corpus mean (-2.9 pp)
  • MALF 71.0% corpus 64.5% · above corpus mean (+6.5 pp)

Lead product-problem code Failure to Deliver is 17% of coded problems · Lead manufacturer BECTON DICKINSON accounts for 45% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Injector, Pen in the event-volume neighbourhood

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

reports

What this shows Injector, Pen carries 665 MAUDE reports, ranked #777 of 1000.

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

Event Types

Malfunction 472 (71.0%)
Injury 183 (27.5%)
Other 6 (0.9%)
3 (0.5%)
Death 1 (0.2%)

Patient Outcomes

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

346 (49.9%)
Other 176 (25.4%)
Hospitalization 108 (15.6%)
Required Intervention 26 (3.8%)
O 19 (2.7%)
Life Threatening 8 (1.2%)
L 4 (0.6%)
R 4 (0.6%)
H 1 (0.1%)
Death 1 (0.1%)

Top Product Problems

Failure to Deliver 41
Break 39
Leak/Splash 23
Defective Device 16
Component Missing 13
Misconnection 13
Fluid/Blood Leak 12
Mechanical Problem 12
Failure to Fire 10
Physical Resistance/Sticking 10
Adverse Event Without Identified Device or Use Problem 8
Insufficient Information 7
Material Twisted/Bent 7
Defective Component 6
Mechanical Jam 6
Device Markings/Labelling Problem 5
Device Operates Differently Than Expected 5
Crack 4
Device Damaged Prior to Use 4
Material Protrusion/Extrusion 4

Yearly Trend

04
2004: 7
08
2008: 1
09
2009: 36
10
2010: 105
11
2011: 91
12
2012: 46
13
2013: 22
14
2014: 34
15
2015: 55
16
2016: 38
17
2017: 9
18
2018: 16
19
2019: 90
20
2020: 34
21
2021: 22
22
2022: 9
23
2023: 15
24
2024: 27
25
2025: 7
26
2026: 1

Related Entities for Injector, Pen

Top Manufacturers

Event Locations

435 (65.4%)
I 170 (25.6%)
NO INFORMATION 56 (8.4%)
HOSPITAL 3 (0.5%)
HOME 1 (0.2%)

Compare BECTON DICKINSON vs BECTON DICKINSON AND CO. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Injector, Pen, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for Injector, Pen 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, Pen; 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.