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2026 data FDA MAUDE openFDA FDA Class II

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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).

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FDA MAUDE casebook

openFDA event book Closed Antineoplastic And Hazardous Drug Re… LIGHT-BOOK · MAUDE

#331 of 1000 · 4,732 reports · 2012–2026

  • BOOK 4,732 reports
  • RANK #331 of 1000
  • DEATH 0 death-typed
  • INJ 101 injury-typed
  • MALF 4,607 malfunction
  • SPAN 2012–2026
  • PEAK 2025: 947
  • PHOTO Staple, Removable

Nearest event-volume peer: Staple, Removable (Skin) (11 report gap)

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System sits #331 of 1000 among tracked device types with 4,732 MAUDE reports spanning 2012–2026. 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

Closed Antineoplastic And Hazardous Drug Re… carries 97.4% MALFUNCTION-coded reports, 32.5pp 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 2.1% corpus 30.3% · below corpus mean (-28.2 pp)
  • MALF 97.4% corpus 64.8% · above corpus mean (+32.5 pp)

Lead product-problem code Leak/Splash is 30% of coded problems · Lead manufacturer BECTON DICKINSON, S.A. accounts for 45% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Closed Antineoplastic And Hazardous Drug Re… in the event-volume neighbourhood

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

reports

What this shows Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System carries 4,732 MAUDE reports, ranked #331 of 1000.

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

Event Types

Malfunction 4,607 (97.4%)
Injury 101 (2.1%)
Other 15 (0.3%)
9 (0.2%)

Patient Outcomes

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

3,616 (79.0%)
Other 893 (19.5%)
Required Intervention 59 (1.3%)
Hospitalization 4 (0.1%)
R 3 (0.1%)
O 2 (0.0%)
S 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Leak/Splash 1,435
Fluid/Blood Leak 1,114
Device Contamination with Chemical or Other Material 384
Disconnection 374
Break 244
Contamination 144
Material Separation 143
No Flow 121
Infusion or Flow Problem 111
Particulates 109
Detachment of Device or Device Component 81
Defective Component 76
Loose or Intermittent Connection 65
Air/Gas in Device 60
Connection Problem 59
Difficult or Delayed Activation 51
Crack 50
Separation Problem 38
Contamination /Decontamination Problem 34
Complete Blockage 29

Yearly Trend

12
2012: 1
13
2013: 2
14
2014: 3
15
2015: 4
16
2016: 13
17
2017: 66
18
2018: 228
19
2019: 464
20
2020: 442
21
2021: 548
22
2022: 448
23
2023: 456
24
2024: 686
25
2025: 947
26
2026: 424

Reports rose to 947 in 2025, up from an average of 571 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Top Manufacturers

BECTON DICKINSON, S.A. 1,910
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 1,386
BECTON DICKINSON 883
ICU MEDICAL, INC. 94
ICU MEDICAL INC. 17

Event Locations

3,052 (64.5%)
I 1,455 (30.7%)
HOSPITAL 86 (1.8%)
NO INFORMATION 86 (1.8%)
OUTPATIENT TREATMENT FACILITY 46 (1.0%)
HOME 3 (0.1%)
OTHER 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare BECTON DICKINSON, S.A. vs ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. →

Nationwide devices with a comparable report-volume footprint

Closed Antineoplastic And Hazardous Drug Re… 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 (4,732 here).

Staple, Removable 4,743 Ventilator, Emergency, Powered 4,749 System, Nuclear Magnetic Resonance Imaging 4,713 Apparatus 4,706

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 Closed Antineoplastic And Hazardous Drug Re… 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 Closed Antineoplastic And Hazardous Drug Re…; 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.