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Needle, Conduction, Anesthetic (W/Wo Introducer)

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Needle, Conduction, Anesthetic (W/Wo Introducer)

The FDA MAUDE database aggregates 1,266 adverse-event reports for Needle, Conduction, Anesthetic (W/Wo Introducer) spanning the period from 1992 through 2026. Of these, 3 are classified as death reports, 371 as injury reports, and 783 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 13 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Break topping the list at 233 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 34 years of MAUDE data, with the peak single-year volume reaching 152 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 11 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

1,266
Total Reports
3
Death Reports
371
Injury Reports
783
Malfunctions

Event Types

Malfunction 783 (61.8%)
Injury 371 (29.3%)
Other 101 (8.0%)
8 (0.6%)
Death 3 (0.2%)

Patient Outcomes

459 (34.2%)
Other 420 (31.3%)
Required Intervention 333 (24.8%)
R 74 (5.5%)
Hospitalization 26 (1.9%)
Life Threatening 15 (1.1%)
Disability 6 (0.4%)
O 3 (0.2%)
Death 3 (0.2%)
S 2 (0.1%)
H 1 (0.1%)
L 1 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Break 233
Leak/Splash 89
Product Quality Problem 48
Fracture 47
Nonstandard Device 45
No Flow 43
Fluid/Blood Leak 42
Manufacturing, Packaging or Shipping Problem 39
Crack 29
Device Markings/Labelling Problem 28
Partial Blockage 28
Complete Blockage 24
Device Handling Problem 23
Detachment of Device or Device Component 22
Packaging Problem 18
Defective Component 17
Device Operates Differently Than Expected 17
Loss of or Failure to Bond 17
Device Contamination with Chemical or Other Material 14
Patient-Device Incompatibility 14

Yearly Trend

92
1992: 2
93
1993: 2
94
1994: 2
96
1996: 8
97
1997: 20
98
1998: 6
99
1999: 9
00
2000: 11
01
2001: 9
02
2002: 10
03
2003: 12
04
2004: 21
05
2005: 31
06
2006: 30
07
2007: 26
08
2008: 24
09
2009: 30
10
2010: 49
11
2011: 33
12
2012: 20
13
2013: 32
14
2014: 41
15
2015: 38
16
2016: 152
17
2017: 34
18
2018: 69
19
2019: 86
20
2020: 78
21
2021: 52
22
2022: 84
23
2023: 75
24
2024: 66
25
2025: 87
26
2026: 17

Related Entities for Needle, Conduction, Anesthetic (W/Wo Introducer)

Event Locations

649 (51.3%)
I 410 (32.4%)
HOSPITAL 136 (10.7%)
NO INFORMATION 35 (2.8%)
OUTPATIENT TREATMENT FACILITY 13 (1.0%)
INVALID DATA 7 (0.6%)
OTHER 7 (0.6%)
AMBULATORY SURGICAL FACILITY 4 (0.3%)
UNKNOWN 3 (0.2%)
NOT APPLICABLE 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.