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2026 data FDA MAUDE openFDA FDA Class I

Needle, Aspiration And Injection, Disposable

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4800 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Needle, Aspiration And Injection, Disposable LIGHT-BOOK · MAUDE

#525 of 1000 · 1,796 reports · 1992–2026

  • BOOK 1,796 reports
  • RANK #525 of 1000
  • DEATH 1 death-typed
  • INJ 339 injury-typed
  • MALF 1,413 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 351
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Elbow, Hemi-, Radial, Polymer (3 report gap)

Needle, Aspiration And Injection, Disposable sits #525 of 1000 among tracked device types with 1,796 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

Needle, Aspiration And Injection, Disposable carries 78.7% MALFUNCTION-coded reports, 13.8pp 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 (-1.5 pp)
  • INJ 18.9% corpus 30.3% · below corpus mean (-11.4 pp)
  • MALF 78.7% corpus 64.8% · above corpus mean (+13.8 pp)

Lead product-problem code Device Contamination with Chemical or Other Material is 23% of coded problems · Lead manufacturer BD MEDICAL (BD WEST) MEDICAL SURGICAL accounts for 52% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Needle, Aspiration And Injection, Disposable in the event-volume neighbourhood

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

reports

What this shows Needle, Aspiration And Injection, Disposable carries 1,796 MAUDE reports, ranked #525 of 1000.

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

Event Types

Malfunction 1,413 (78.7%)
Injury 339 (18.9%)
Other 30 (1.7%)
13 (0.7%)
Death 1 (0.1%)

Patient Outcomes

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

1,022 (55.6%)
Other 565 (30.7%)
Required Intervention 139 (7.6%)
Hospitalization 42 (2.3%)
R 32 (1.7%)
O 12 (0.7%)
H 10 (0.5%)
Disability 6 (0.3%)
Life Threatening 5 (0.3%)
L 2 (0.1%)
Death 2 (0.1%)
S 1 (0.1%)

Top Product Problems

Device Contamination with Chemical or Other Material 363
Break 286
Defective Component 229
Adverse Event Without Identified Device or Use Problem 167
Contamination 83
Leak/Splash 65
Contamination /Decontamination Problem 57
Detachment Of Device Component 53
Packaging Problem 34
Complete Blockage 33
Device, or device fragments remain in patient 30
Dull, Blunt 26
Difficult to Remove 24
Fracture 24
Entrapment of Device 23
Tip breakage 21
Detachment of Device or Device Component 20
Device Operates Differently Than Expected 20
Bent 19
Insufficient Device Problem Information 19

Yearly Trend

92
1992: 3
93
1993: 3
94
1994: 16
95
1995: 13
96
1996: 4
97
1997: 6
98
1998: 13
99
1999: 10
00
2000: 10
01
2001: 13
02
2002: 7
03
2003: 7
04
2004: 13
05
2005: 5
06
2006: 9
07
2007: 12
08
2008: 32
09
2009: 20
10
2010: 18
11
2011: 9
12
2012: 24
13
2013: 33
14
2014: 24
15
2015: 32
16
2016: 45
17
2017: 85
18
2018: 122
19
2019: 153
20
2020: 102
21
2021: 108
22
2022: 74
23
2023: 118
24
2024: 181
25
2025: 351
26
2026: 121

Reports rose to 351 in 2025, up from an average of 150 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Needle, Aspiration And Injection, Disposable

Top Manufacturers

BD MEDICAL (BD WEST) MEDICAL SURGICAL 586
BECTON DICKINSON 413
DEPUY SYNTHES SPINE 38
DEPUY SPINE INC 32
COOK ENDOSCOPY 27
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG 21

Event Locations

1,018 (56.7%)
I 544 (30.3%)
HOSPITAL 164 (9.1%)
NO INFORMATION 32 (1.8%)
OTHER 24 (1.3%)
OUTPATIENT TREATMENT FACILITY 7 (0.4%)
INVALID DATA 5 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
HOME 1 (0.1%)

Compare BD MEDICAL (BD WEST) MEDICAL SURGICAL vs BECTON DICKINSON →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Needle, Aspiration And Injection, Disposable: 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 (1,796 here).

Prosthesis, Elbow, Hemi-, Radial, Polymer 1,793 Operating Room Accessories Table Tray 1,802 Over-The-Counter Automated External Defibri… 1,803 System, Ablation, Microwave And Accessories 1,784

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Needle, Aspiration And Injection, Disposable 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 Needle, Aspiration And Injection, Disposable; 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.