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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Stopcock, I.V. Set LIGHT-BOOK · MAUDE

#297 of 1000 · 5,518 reports · 1992–2026

  • BOOK 5,518 reports
  • RANK #297 of 1000
  • DEATH 25 death-typed
  • INJ 345 injury-typed
  • MALF 5,098 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 935
  • PHOTO Pump, Breast, Powered

Nearest event-volume peer: Pump, Breast, Powered (22 report gap)

Stopcock, I.V. Set sits #297 of 1000 among tracked device types with 5,518 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 →

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 0.5% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 6.3% corpus 30.4% · below corpus mean (-24.2 pp)
  • MALF 92.4% corpus 64.5% · above corpus mean (+27.9 pp)

Lead product-problem code Fluid/Blood Leak is 38% 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 69% 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 5,518 MAUDE reports, ranked #297 of 1000.

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

Event Types

Malfunction 5,098 (92.4%)
Injury 345 (6.3%)
25 (0.5%)
Death 25 (0.5%)
Other 25 (0.5%)

Patient Outcomes

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

4,602 (82.8%)
Other 573 (10.3%)
Required Intervention 192 (3.5%)
Life Threatening 55 (1.0%)
R 43 (0.8%)
Death 32 (0.6%)
Hospitalization 24 (0.4%)
L 17 (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 1,799
Leak/Splash 680
Disconnection 392
Crack 323
No Flow 255
Break 221
Device Contamination with Chemical or Other Material 157
Material Separation 157
Air/Gas in Device 120
Connection Problem 82
Loose or Intermittent Connection 75
Particulates 68
Detachment of Device or Device Component 65
Infusion or Flow Problem 61
Separation Problem 58
Backflow 45
Defective Component 41
Contamination 32
Material Split, Cut or Torn 29
Obstruction of Flow 27

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: 877
26
2026: 138

Related Entities for Stopcock, I.V. Set

Top Manufacturers

ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 2,313
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 902
BAXTER HEALTHCARE CORPORATION 259
BAXTER HEALTHCARE - AIBONITO 221
ICU MEDICAL, INC. 211
SMITHS MEDICAL ASD, INC. 194
BAXTER HEALTHCARE CORP. 116
BAXTER HEALTHCARE - MALTA 94
BECTON DICKINSON 87

Event Locations

3,815 (69.1%)
I 1,224 (22.2%)
HOSPITAL 425 (7.7%)
INVALID DATA 26 (0.5%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Stopcock, I.V. Set, 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 (5,518 here).

Pump, Breast, Powered 5,540 Warmer, Infant Radiant 5,554 Stent, Ureteral 5,594 Prosthesis 5,609

Similar death-typed counts

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

Agent 25 Aid, Transfer 25 Analyzer, Chemistry, For Clinical Use 25 Appliance 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.