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2026 data FDA MAUDE openFDA FDA Class II

Stopcock, I.V. Set

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 Stopcock, I.V. Set LIGHT-BOOK · MAUDE

#290 of 1000 · 5,928 reports · 1992–2026

  • BOOK 5,928 reports
  • RANK #290 of 1000
  • DEATH 25 death-typed
  • INJ 362 injury-typed
  • MALF 5,491 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 935
  • PHOTO Instrument

Nearest event-volume peer: Instrument, Vitreous Aspiration And Cutting, Ac-Powered (14 report gap)

Stopcock, I.V. Set sits #290 of 1000 among tracked device types with 5,928 MAUDE reports spanning 1992–2026. 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

Stopcock, I.V. Set carries 92.6% MALFUNCTION-coded reports, 27.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 6.1% corpus 30.3% · below corpus mean (-24.2 pp)
  • MALF 92.6% corpus 64.8% · above corpus mean (+27.8 pp)

Lead product-problem code Fluid/Blood Leak is 36% of coded problems · Lead manufacturer ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. accounts for 53% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Stopcock, I.V. Set in the event-volume neighbourhood

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

reports

What this shows Stopcock, I.V. Set carries 5,928 MAUDE reports, ranked #290 of 1000.

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

Event Types

Malfunction 5,491 (92.6%)
Injury 362 (6.1%)
25 (0.4%)
Death 25 (0.4%)
Other 25 (0.4%)

Patient Outcomes

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

4,996 (83.4%)
Other 579 (9.7%)
Required Intervention 216 (3.6%)
Life Threatening 57 (1.0%)
R 43 (0.7%)
Death 32 (0.5%)
Hospitalization 24 (0.4%)
L 19 (0.3%)
S 8 (0.1%)
O 4 (0.1%)
H 3 (0.1%)
Disability 3 (0.1%)
D 2 (0.0%)
Congenital Anomaly 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 2,237
Leak/Splash 1,002
Crack 604
Disconnection 540
Break 312
No Flow 303
Material Separation 231
Device Contamination with Chemical or Other Material 161
Connection Problem 134
Air/Gas in Device 120
Loose or Intermittent Connection 102
Detachment Of Device Component 79
Particulates 76
Detachment of Device or Device Component 70
Infusion or Flow Problem 66
Backflow 60
Separation Problem 60
Replace 48
Contamination 44
Defective Component 42

Yearly Trend

92
1992: 10
93
1993: 4
94
1994: 8
95
1995: 9
96
1996: 20
97
1997: 55
98
1998: 49
99
1999: 69
00
2000: 64
01
2001: 73
02
2002: 40
03
2003: 34
04
2004: 21
05
2005: 30
06
2006: 20
07
2007: 26
08
2008: 48
09
2009: 27
10
2010: 131
11
2011: 95
12
2012: 93
13
2013: 117
14
2014: 105
15
2015: 96
16
2016: 148
17
2017: 114
18
2018: 164
19
2019: 400
20
2020: 284
21
2021: 245
22
2022: 280
23
2023: 689
24
2024: 935
25
2025: 878
26
2026: 547

Reports in 2025 (878) held close to the prior two-year average of 812.

Related Entities for Stopcock, I.V. Set

Top Manufacturers

ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 2,519
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 999
BAXTER HEALTHCARE CORPORATION 267
ICU MEDICAL, INC. 266
BAXTER HEALTHCARE - AIBONITO 221
SMITHS MEDICAL ASD, INC. 195
BAXTER HEALTHCARE CORP. 116
BAXTER HEALTHCARE - MALTA 94
BECTON DICKINSON 88

Event Locations

4,222 (71.2%)
I 1,224 (20.6%)
HOSPITAL 428 (7.2%)
INVALID DATA 26 (0.4%)
NO INFORMATION 11 (0.2%)
OUTPATIENT TREATMENT FACILITY 6 (0.1%)
UNKNOWN 4 (0.1%)
OTHER 3 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. vs BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stopcock, I.V. Set: 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 (5,928 here).

Instrument 5,942 Catheter 5,946 Mesh 5,966 Drug-Eluting Peripheral Transluminal Angiop… 5,888

Similar death-typed counts

Nearest other device types by death-typed report count (25 here), distinct from the volume row.

Aid, Transfer 25 Analyzer, Chemistry, For Clinical Use 25 Hemostatic Metal Clip For The Gi Tract 25 Shunt, Portosystemic, Endoprosthesis 25

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

Disclaimer: MAUDE figures for Stopcock, I.V. Set 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 Stopcock, I.V. Set; 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.