2026 data FDA MAUDE openFDA FDA Class II

Epidural Anesthesia Kit

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 §868.5120 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Epidural Anesthesia Kit LIGHT-BOOK · MAUDE

#636 of 1000 · 1,130 reports · 2008–2026

  • BOOK 1,130 reports
  • RANK #636 of 1000
  • DEATH 0 death-typed
  • INJ 98 injury-typed
  • MALF 1,030 malfunction
  • SPAN 2008–2026
  • PEAK 2019: 341
  • PHOTO Pulmonic Valved Condu…

Nearest event-volume peer: Pulmonic Valved Conduit (3 report gap)

Epidural Anesthesia Kit sits #636 of 1000 among tracked device types with 1,130 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 →

Malfunction reports run above the device-type norm

Epidural Anesthesia Kit carries 91.2% MALFUNCTION-coded reports, 26.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 8.7% corpus 30.3% · below corpus mean (-21.6 pp)
  • MALF 91.2% corpus 64.8% · above corpus mean (+26.3 pp)

Lead product-problem code Break is 35% of coded problems · Lead manufacturer B. BRAUN MEDICAL INC. accounts for 44% of manufacturer-tagged reports · Top event location I is 47% of location-tagged rows .

Epidural Anesthesia Kit in the event-volume neighbourhood

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

reports

What this shows Epidural Anesthesia Kit carries 1,130 MAUDE reports, ranked #636 of 1000.

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

Event Types

Malfunction 1,030 (91.2%)
Injury 98 (8.7%)
2 (0.2%)

Patient Outcomes

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

952 (83.1%)
Required Intervention 83 (7.2%)
Other 78 (6.8%)
R 14 (1.2%)
Hospitalization 14 (1.2%)
O 2 (0.2%)
Life Threatening 2 (0.2%)
L 1 (0.1%)

Top Product Problems

Break 356
Detachment of Device or Device Component 242
Fluid/Blood Leak 105
Leak/Splash 51
Contamination /Decontamination Problem 33
Difficult to Advance 25
Difficult to Remove 20
Difficult To Position 17
Failure to Infuse 16
Material Fragmentation 16
Obstruction of Flow 16
Material Separation 15
Material Split, Cut or Torn 14
Physical Resistance 14
Connection Problem 13
Physical Resistance/Sticking 12
Loose or Intermittent Connection 11
Device Damaged Prior to Use 10
Fracture 10
Infusion or Flow Problem 10

Yearly Trend

08
2008: 3
12
2012: 1
13
2013: 3
14
2014: 33
15
2015: 96
16
2016: 11
17
2017: 65
18
2018: 80
19
2019: 341
20
2020: 76
21
2021: 41
22
2022: 77
23
2023: 63
24
2024: 102
25
2025: 98
26
2026: 40

Reports in 2025 (98) held close to the prior two-year average of 83.

Related Entities for Epidural Anesthesia Kit

Event Locations

I 529 (46.8%)
440 (38.9%)
HOSPITAL 143 (12.7%)
NO INFORMATION 15 (1.3%)
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 a comparable report-volume footprint

Epidural Anesthesia Kit carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,130 here).

Similar death-typed counts

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

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.