2026 data FDA MAUDE openFDA

Needle, Hypodermic, Single Lumen

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 Needle, Hypodermic, Single Lumen MID-BOOK · MAUDE

#83 of 1000 · 39,044 reports · 1993–2026

  • BOOK 39,044 reports
  • RANK #83 of 1000
  • DEATH 65 death-typed
  • INJ 4,059 injury-typed
  • MALF 34,255 malfunction
  • SPAN 1993–2026
  • PEAK 2023: 4,986
  • PHOTO Mesh

Nearest event-volume peer: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (470 report gap)

Needle, Hypodermic, Single Lumen sits #83 of 1000 among tracked device types with 39,044 MAUDE reports spanning 1993–2026. 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 10.4% corpus 30.4% · below corpus mean (-20.0 pp)
  • MALF 87.7% corpus 64.5% · above corpus mean (+23.2 pp)

Lead product-problem code Failure to Deliver is 23% of coded problems · Lead manufacturer BECTON DICKINSON AND CO. accounts for 30% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Needle, Hypodermic, Single Lumen in the event-volume neighbourhood

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

reports

What this shows Needle, Hypodermic, Single Lumen carries 39,044 MAUDE reports, ranked #83 of 1000.

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

Event Types

Malfunction 34,255 (87.7%)
Injury 4,059 (10.4%)
Other 538 (1.4%)
126 (0.3%)
Death 65 (0.2%)
No answer provided 1 (0.0%)

Patient Outcomes

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

24,625 (62.6%)
Other 11,713 (29.8%)
Required Intervention 2,109 (5.4%)
Hospitalization 380 (1.0%)
R 237 (0.6%)
O 82 (0.2%)
Death 78 (0.2%)
Disability 38 (0.1%)
Life Threatening 37 (0.1%)
S 29 (0.1%)
H 18 (0.0%)
L 14 (0.0%)
D 5 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Failure to Deliver 6,951
Break 4,057
Complete Blockage 3,386
Leak/Splash 3,270
Device Contamination with Chemical or Other Material 2,094
Misconnection 1,124
Defective Device 1,108
Fluid/Blood Leak 1,097
Detachment of Device or Device Component 918
Device Markings/Labelling Problem 855
Difficult or Delayed Activation 825
Defective Component 597
Detachment Of Device Component 535
Product Quality Problem 519
Material Protrusion/Extrusion 503
Material Twisted/Bent 498
Packaging Problem 484
Component Missing 408
Contamination 353
Crack 346

Yearly Trend

93
1993: 3
94
1994: 14
95
1995: 16
96
1996: 51
97
1997: 89
98
1998: 80
99
1999: 59
00
2000: 45
01
2001: 110
02
2002: 125
03
2003: 148
04
2004: 199
05
2005: 182
06
2006: 236
07
2007: 208
08
2008: 177
09
2009: 263
10
2010: 249
11
2011: 240
12
2012: 215
13
2013: 255
14
2014: 287
15
2015: 567
16
2016: 941
17
2017: 1,547
18
2018: 2,398
19
2019: 4,896
20
2020: 4,245
21
2021: 4,532
22
2022: 4,885
23
2023: 4,986
24
2024: 4,053
25
2025: 2,491
26
2026: 252

Related Entities for Needle, Hypodermic, Single Lumen

Event Locations

19,228 (49.2%)
I 16,831 (43.1%)
HOSPITAL 1,292 (3.3%)
NO INFORMATION 654 (1.7%)
OUTPATIENT TREATMENT FACILITY 297 (0.8%)
OTHER 259 (0.7%)
HOME 202 (0.5%)
NOT APPLICABLE 92 (0.2%)
UNKNOWN 79 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 33 (0.1%)
INVALID DATA 32 (0.1%)
AMBULATORY SURGICAL FACILITY 29 (0.1%)
NURSING HOME 7 (0.0%)
CLINIC - WALK IN, OTHER 4 (0.0%)
OUTPATIENT CLINIC/SURGERY 2 (0.0%)
AMBULATORY HEALTH CARE FACILITY 1 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)
LABORATORY 1 (0.0%)

Compare BECTON DICKINSON AND CO. vs BECTON DICKINSON →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Needle, Hypodermic, Single Lumen, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (39,044 here).

Similar death-typed counts

Nearest other device types by death-typed report count (65 here), distinct from the volume row.

Disclaimer: MAUDE figures for Needle, Hypodermic, Single Lumen 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, Hypodermic, Single Lumen; 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.