What are FDA adverse event reports for Epidural Anesthesia Kit?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Epidural Anesthesia Kit, there are 1,100 total reports including 0 death reports and 95 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Epidural Anesthesia Kit?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Epidural Anesthesia Kit

Name: Epidural Anesthesia Kit - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Epidural Anesthesia Kit LIGHT-BOOK · MAUDE

#630 of 1000 · 1,100 reports · 2008–2026

BOOK 1,100 reports
RANK #630 of 1000
DEATH 0 death-typed
INJ 95 injury-typed
MALF 1,003 malfunction
SPAN 2008–2026
PEAK 2019: 341
PHOTO Intervertebral Fusion…

Nearest event-volume peer: Intervertebral Fusion Device With Bone Graft, Cervical (3 report gap)

Epidural Anesthesia Kit sits #630 of 1000 among tracked device types with 1,100 MAUDE reports spanning 2008–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
INJ 8.6% corpus 30.4% · below corpus mean (-21.8 pp)
MALF 91.2% corpus 64.5% · above corpus mean (+26.7 pp)

Lead product-problem code Break is 37% of coded problems · Lead manufacturer B. BRAUN MEDICAL INC. accounts for 43% of manufacturer-tagged reports · Top event location I is 48% of location-tagged rows .

Pulmonic Valv…

1,107
Agent

1,104
Intervertebra…

1,103
Epidural Anes… (this)

1,100
Dilator

1,095
Growing Rod S…

1,094

What this shows Epidural Anesthesia Kit carries 1,100 MAUDE reports, ranked #630 of 1000.

Event Types

Malfunction 1,003 (91.2%)

Injury 95 (8.6%)

2 (0.2%)

Patient Outcomes

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

929 (83.2%)

Required Intervention 80 (7.2%)

Other 74 (6.6%)

R 14 (1.3%)

Hospitalization 14 (1.3%)

O 2 (0.2%)

Life Threatening 2 (0.2%)

L 1 (0.1%)

Yearly Trend

2008: 3

2012: 1

2013: 3

2014: 33

2015: 96

2016: 11

2017: 65

2018: 80

2019: 341

2020: 76

2021: 41

2022: 77

2023: 63

2024: 102

2025: 98

2026: 10

Top Manufacturers

B. BRAUN MEDICAL INC. 416

ARROW INTERNATIONAL INC. 243

B. BRAUN MELSUNGEN AG 175

B. BRAUN MEDICAL, INC. 41

B BRAUN MELSUNGEN AG 34

ARROW INTERNATIONAL LLC 21

SMITHS MEDICAL ASD, INC. 20

ARROW INTL., INC. 14

SMITHS MEDICAL ASD; INC. 9

Event Locations

I 529 (48.1%)

412 (37.5%)

HOSPITAL 141 (12.8%)

NO INFORMATION 15 (1.4%)

AMBULATORY SURGICAL FACILITY 1 (0.1%)

HOME 1 (0.1%)

OTHER 1 (0.1%)

Compare B. BRAUN MEDICAL INC. vs ARROW INTERNATIONAL INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Epidural Anesthesia Kit, 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 (1,100 here).

Intervertebral Fusion Device With Bone Graft 1,103 Agent 1,104 Dilator, Catheter, Ureteral 1,095 Growing Rod System- Magnetic Actuation 1,094

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Epidural Anesthesia Kit 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 Epidural Anesthesia Kit; 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.

Epidural Anesthesia Kit

Event-type mix vs corpus