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2026 data FDA MAUDE openFDA FDA Class II

System/Device, Pharmacy Compounding

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 §880.5440 (General Hospital panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book System/Device, Pharmacy Compounding LIGHT-BOOK · MAUDE

#617 of 1000 · 1,226 reports · 2002–2026

  • BOOK 1,226 reports
  • RANK #617 of 1000
  • DEATH 7 death-typed
  • INJ 41 injury-typed
  • MALF 1,137 malfunction
  • SPAN 2002–2026
  • PEAK 2012: 257
  • PHOTO Tube

Nearest event-volume peer: Tube, Gastro-Enterostomy (2 report gap)

System/Device, Pharmacy Compounding sits #617 of 1000 among tracked device types with 1,226 MAUDE reports spanning 2002–2026. 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

System/Device, Pharmacy Compounding carries 92.7% MALFUNCTION-coded reports, 27.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 3.3% corpus 30.3% · below corpus mean (-26.9 pp)
  • MALF 92.7% corpus 64.8% · above corpus mean (+27.9 pp)

Lead product-problem code Break is 15% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 53% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

System/Device, Pharmacy Compounding in the event-volume neighbourhood

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

reports

What this shows System/Device, Pharmacy Compounding carries 1,226 MAUDE reports, ranked #617 of 1000.

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

Event Types

Malfunction 1,137 (92.7%)
Injury 41 (3.3%)
29 (2.4%)
Other 12 (1.0%)
Death 7 (0.6%)

Patient Outcomes

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

1,029 (82.9%)
Other 153 (12.3%)
Required Intervention 15 (1.2%)
R 11 (0.9%)
Life Threatening 11 (0.9%)
L 6 (0.5%)
Death 6 (0.5%)
Hospitalization 6 (0.5%)
Disability 4 (0.3%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Break 174
Fluid/Blood Leak 168
Leak/Splash 106
Mechanical Problem 88
Device Operates Differently Than Expected 84
Application Program Problem: Dose Calculation Error 67
Disconnection 60
Output Problem 42
Incorrect, Inadequate or Imprecise Result or Readings 39
Application Program Problem 38
Improper or Incorrect Procedure or Method 38
Material Separation 36
Device Contamination with Chemical or Other Material 28
Device Inoperable 28
Product Quality Problem 27
Inadequate User Interface 25
Device Displays Incorrect Message 24
Excess Flow or Over-Infusion 24
Device Alarm System 22
Material Frayed 20

Yearly Trend

02
2002: 1
04
2004: 2
05
2005: 2
08
2008: 4
09
2009: 4
10
2010: 17
11
2011: 121
12
2012: 257
13
2013: 28
14
2014: 7
15
2015: 39
16
2016: 32
17
2017: 27
18
2018: 65
19
2019: 137
20
2020: 80
21
2021: 130
22
2022: 77
23
2023: 91
24
2024: 46
25
2025: 29
26
2026: 30

Reports fell to 29 in 2025, down from an average of 69 in the two years before.

Related Entities for System/Device, Pharmacy Compounding

Top Manufacturers

BAXTER HEALTHCARE CORPORATION 356
BAXTER HEALTHCARE 124
BAXTER HEALTHCARE - LARGO 96
B. BRAUN MEDICAL INC. 57
B. BRAUN MEDICAL INC 45

Event Locations

763 (62.2%)
I 413 (33.7%)
NO INFORMATION 27 (2.2%)
HOSPITAL 22 (1.8%)
HOME 1 (0.1%)

Compare BAXTER HEALTHCARE CORPORATION vs BAXTER HEALTHCARE →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System/Device, Pharmacy Compounding: 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 (1,226 here).

Tube, Gastro-Enterostomy 1,228 Cardiovascular Procedure Kit 1,221 Accessories, Blood Circuit, Hemodialysis 1,220 Hemodialyzer, Re-Use, High Flux 1,219

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7

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

Disclaimer: MAUDE figures for System/Device, Pharmacy Compounding 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 System/Device, Pharmacy Compounding; 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.