2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#334 of 1000 · 4,431 reports · 2012–2026

  • BOOK 4,431 reports
  • RANK #334 of 1000
  • DEATH 0 death-typed
  • INJ 96 injury-typed
  • MALF 4,312 malfunction
  • SPAN 2012–2026
  • PEAK 2025: 947
  • PHOTO Fluorometer

Nearest event-volume peer: Fluorometer, For Clinical Use (7 report gap)

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System sits #334 of 1000 among tracked device types with 4,431 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 →

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 2.2% corpus 30.4% · below corpus mean (-28.3 pp)
  • MALF 97.3% corpus 64.5% · above corpus mean (+32.8 pp)

Lead product-problem code Leak/Splash is 31% of coded problems · Lead manufacturer BECTON DICKINSON, S.A. accounts for 45% of manufacturer-tagged reports · Top event location is 62% 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 4,431 MAUDE reports, ranked #334 of 1000.

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

Event Types

Malfunction 4,312 (97.3%)
Injury 96 (2.2%)
Other 14 (0.3%)
9 (0.2%)

Patient Outcomes

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

3,468 (78.5%)
Other 880 (19.9%)
Required Intervention 57 (1.3%)
R 3 (0.1%)
Hospitalization 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 1,372
Fluid/Blood Leak 1,036
Device Contamination with Chemical or Other Material 380
Disconnection 324
Break 228
Material Separation 141
Contamination 126
Infusion or Flow Problem 105
Particulates 103
No Flow 81
Detachment of Device or Device Component 80
Defective Component 76
Loose or Intermittent Connection 67
Air/Gas in Device 54
Connection Problem 51
Difficult or Delayed Activation 51
Crack 48
Separation Problem 37
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: 123

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

Event Locations

2,757 (62.2%)
I 1,455 (32.8%)
NO INFORMATION 86 (1.9%)
HOSPITAL 83 (1.9%)
OUTPATIENT TREATMENT FACILITY 44 (1.0%)
HOME 3 (0.1%)
OTHER 2 (0.0%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Closed Antineoplastic And Hazardous Drug Re…, 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 (4,431 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 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.