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2026 data FDA MAUDE openFDA FDA Class II

Syringe, Piston

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 §880.5860 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Syringe, Piston MID-BOOK · MAUDE

#67 of 1000 · 52,759 reports · 1992–2026

  • BOOK 52,759 reports
  • RANK #67 of 1000
  • DEATH 66 death-typed
  • INJ 5,213 injury-typed
  • MALF 46,717 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 5,874
  • PHOTO Generator

Nearest event-volume peer: Generator, Oxygen, Portable (26 report gap)

Syringe, Piston sits #67 of 1000 among tracked device types with 52,759 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

Syringe, Piston carries 88.5% MALFUNCTION-coded reports, 23.7pp 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 9.9% corpus 30.3% · below corpus mean (-20.4 pp)
  • MALF 88.5% corpus 64.8% · above corpus mean (+23.7 pp)

Lead product-problem code Leak/Splash is 21% of coded problems · Lead manufacturer COMPANION MEDICAL INC accounts for 23% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Syringe, Piston in the event-volume neighbourhood

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

reports

What this shows Syringe, Piston carries 52,759 MAUDE reports, ranked #67 of 1000.

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

Event Types

Malfunction 46,717 (88.5%)
Injury 5,213 (9.9%)
Other 430 (0.8%)
332 (0.6%)
Death 66 (0.1%)
No answer provided 1 (0.0%)

Patient Outcomes

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

32,354 (61.4%)
Other 16,475 (31.3%)
Hospitalization 1,888 (3.6%)
Required Intervention 1,036 (2.0%)
R 234 (0.4%)
O 231 (0.4%)
Life Threatening 156 (0.3%)
H 107 (0.2%)
Death 71 (0.1%)
Disability 67 (0.1%)
L 63 (0.1%)
S 22 (0.0%)
D 2 (0.0%)
Congenital Anomaly 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Leak/Splash 9,517
Device Contamination with Chemical or Other Material 6,381
Break 4,859
Fluid/Blood Leak 3,204
Patient Device Interaction Problem 2,961
Device Markings/Labelling Problem 2,096
Failure to Deliver 1,905
Volume Accuracy Problem 1,862
Computer Software Problem 1,431
Crack 1,366
Contamination 1,357
Defective Component 1,180
Physical Resistance/Sticking 1,051
Defective Device 922
Material Too Rigid or Stiff 916
Packaging Problem 889
Contamination /Decontamination Problem 843
Material Integrity Problem 704
Detachment of Device or Device Component 627
Data Problem 609

Yearly Trend

92
1992: 2
93
1993: 14
94
1994: 115
95
1995: 73
96
1996: 100
97
1997: 130
98
1998: 136
99
1999: 116
00
2000: 85
01
2001: 140
02
2002: 218
03
2003: 270
04
2004: 321
05
2005: 428
06
2006: 532
07
2007: 674
08
2008: 691
09
2009: 913
10
2010: 679
11
2011: 185
12
2012: 307
13
2013: 326
14
2014: 244
15
2015: 273
16
2016: 684
17
2017: 1,858
18
2018: 3,952
19
2019: 5,863
20
2020: 5,334
21
2021: 5,874
22
2022: 5,233
23
2023: 5,214
24
2024: 5,122
25
2025: 4,245
26
2026: 2,408

Reports in 2025 (4,245) held close to the prior two-year average of 5,168.

Related Entities for Syringe, Piston

Top Manufacturers

COMPANION MEDICAL INC 7,965
BD MEDICAL - DIABETES CARE 7,278
BECTON DICKINSON MEDICAL SYSTEMS 6,136
BECTON DICKINSON 4,898
BECTON DICKINSON, S.A. 4,385
BD MEDICAL (BD WEST) MEDICAL SURGICAL 2,437
MEDTRONIC MINIMED 1,903

Event Locations

28,160 (53.4%)
I 21,509 (40.8%)
HOSPITAL 1,240 (2.4%)
NO INFORMATION 614 (1.2%)
HOME 489 (0.9%)
OUTPATIENT TREATMENT FACILITY 226 (0.4%)
OTHER 190 (0.4%)
UNKNOWN 169 (0.3%)
INVALID DATA 61 (0.1%)
NURSING HOME 50 (0.1%)
AMBULATORY SURGICAL FACILITY 13 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 12 (0.0%)
PUBLIC VENUE 6 (0.0%)
NOT APPLICABLE 4 (0.0%)
AMBULATORY HEALTH CARE FACILITY 3 (0.0%)
CLINIC - WALK IN, OTHER 3 (0.0%)
DIALYSIS CENTER 3 (0.0%)
SCHOOL 3 (0.0%)
OUTPATIENT CLINIC/SURGERY 2 (0.0%)
0 1 (0.0%)
CHEMOTHERAPY CENTER 1 (0.0%)

Compare COMPANION MEDICAL INC vs BD MEDICAL - DIABETES CARE →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Syringe, Piston: 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 (52,759 here).

Generator, Oxygen, Portable 52,785 Stimulator 52,959 Drug Eluting Permanent Left Ventricular Pac… 52,206 Stimulator 51,898

Similar death-typed counts

Nearest other device types by death-typed report count (66 here), distinct from the volume row.

Electrode, Pacemaker, Temporary 65 Needle, Hypodermic, Single Lumen 67 Pancreatic Stent 65 Drug-Eluting Percutaneous Transluminal Coro… 68

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

Disclaimer: MAUDE figures for Syringe, Piston 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 Syringe, Piston; 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.