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2026 data FDA MAUDE openFDA

Set, Administration, Intravascular

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 Set, Administration, Intravascular HEAVY-BOOK · MAUDE

#19 of 1000 · 207,687 reports · 1992–2026

  • BOOK 207,687 reports
  • RANK #19 of 1000
  • DEATH 438 death-typed
  • INJ 21,566 injury-typed
  • MALF 184,170 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 47,209
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, Continuous, Facility Use (2,504 report gap)

Set, Administration, Intravascular sits #19 of 1000 among tracked device types with 207,687 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 10.4% corpus 30.4% · below corpus mean (-20.1 pp)
  • MALF 88.7% corpus 64.5% · above corpus mean (+24.2 pp)

Lead product-problem code Fluid/Blood Leak is 19% of coded problems · Lead manufacturer UNOMEDICAL A/S accounts for 36% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Set, Administration, Intravascular in the event-volume neighbourhood

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

reports

What this shows Set, Administration, Intravascular carries 207,687 MAUDE reports, ranked #19 of 1000.

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

Event Types

Malfunction 184,170 (88.7%)
Injury 21,566 (10.4%)
Other 935 (0.5%)
577 (0.3%)
Death 438 (0.2%)
No answer provided 1 (0.0%)

Patient Outcomes

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

177,788 (82.8%)
Other 12,815 (6.0%)
Required Intervention 10,649 (5.0%)
Hospitalization 4,532 (2.1%)
R 3,825 (1.8%)
H 2,197 (1.0%)
Life Threatening 861 (0.4%)
L 551 (0.3%)
O 486 (0.2%)
Death 476 (0.2%)
Disability 313 (0.1%)
S 111 (0.1%)
Congenital Anomaly 49 (0.0%)
D 15 (0.0%)
Invalid Data 4 (0.0%)
C 2 (0.0%)

Top Product Problems

Fluid/Blood Leak 27,956
Material Twisted/Bent 27,033
Leak/Splash 22,613
Detachment of Device or Device Component 10,790
Infusion or Flow Problem 9,378
Loss of or Failure to Bond 8,939
Complete Blockage 4,927
Device Alarm System 4,901
Break 4,370
Disconnection 3,807
Adverse Event Without Identified Device or Use Problem 3,747
Crack 3,279
Material Separation 3,278
Air/Gas in Device 2,858
Material Deformation 2,419
No Apparent Adverse Event 2,368
No Flow 2,111
Device Handling Problem 1,798
Insufficient Flow or Under Infusion 1,682
Obstruction of Flow 1,558

Yearly Trend

92
1992: 15
93
1993: 25
94
1994: 266
95
1995: 285
96
1996: 388
97
1997: 701
98
1998: 809
99
1999: 677
00
2000: 761
01
2001: 892
02
2002: 1,196
03
2003: 1,288
04
2004: 1,018
05
2005: 953
06
2006: 1,035
07
2007: 1,499
08
2008: 1,941
09
2009: 2,512
10
2010: 2,536
11
2011: 4,407
12
2012: 4,930
13
2013: 4,651
14
2014: 4,694
15
2015: 6,625
16
2016: 8,470
17
2017: 6,462
18
2018: 6,574
19
2019: 11,227
20
2020: 9,563
21
2021: 10,414
22
2022: 13,393
23
2023: 10,916
24
2024: 47,209
25
2025: 35,090
26
2026: 4,265

Related Entities for Set, Administration, Intravascular

Top Manufacturers

UNOMEDICAL A/S 39,713
CAREFUSION 13,682
UNOMEDICAL DEVICES S.A. DE C.V. 11,201
UNOMEDICAL UM-D 8,879
BAXTER HEALTHCARE CORPORATION 8,538
ST PAUL 7,777
SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 6,638
SMITHS MEDICAL ASD, INC. 6,541
SISTEMAS MEDICOS ALARIS S.A. DE C.V. 6,516

Event Locations

141,812 (68.3%)
I 48,159 (23.2%)
HOSPITAL 9,036 (4.4%)
OTHER 2,999 (1.4%)
NO INFORMATION 1,579 (0.8%)
HOME 1,353 (0.7%)
U 781 (0.4%)
NOT APPLICABLE 735 (0.4%)
OUTPATIENT TREATMENT FACILITY 536 (0.3%)
UNKNOWN 306 (0.1%)
INVALID DATA 303 (0.1%)
AMBULATORY SURGICAL FACILITY 28 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 26 (0.0%)
NURSING HOME 12 (0.0%)
CHEMOTHERAPY CENTER 9 (0.0%)
SCHOOL 9 (0.0%)
IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

Compare UNOMEDICAL A/S vs CAREFUSION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Set, Administration, Intravascular, 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 (207,687 here).

Ventilator, Continuous, Facility Use 205,183 Prosthesis 214,814 Drug Eluting Permanent Right Ventricular Or… 218,060 Mesh, Surgical, Polymeric 168,757

Similar death-typed counts

Nearest other device types by death-typed report count (438 here), distinct from the volume row.

Catheter, Intravascular, Diagnostic 444 Oxygenator, Cardiopulmonary Bypass 445 Electrosurgical 456 Lift, Patient, Non-Ac-Powered 412

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

Disclaimer: MAUDE figures for Set, Administration, Intravascular 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 Set, Administration, Intravascular; 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.