2026 data FDA MAUDE openFDA FDA Class II

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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 §880.5200 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Catheter MID-BOOK · MAUDE

#72 of 1000 · 48,999 reports · 1992–2026

  • BOOK 48,999 reports
  • RANK #72 of 1000
  • DEATH 141 death-typed
  • INJ 6,441 injury-typed
  • MALF 40,892 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 5,188
  • PHOTO Tubes

Nearest event-volume peer: Tubes, Vials, Systems, Serum Separators, Blood Collection (343 report gap)

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days sits #72 of 1000 among tracked device types with 48,999 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

Catheter carries 83.5% MALFUNCTION-coded reports, 18.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 13.1% corpus 30.3% · below corpus mean (-17.1 pp)
  • MALF 83.5% corpus 64.8% · above corpus mean (+18.6 pp)

Lead product-problem code Leak/Splash is 26% of coded problems · Lead manufacturer BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. accounts for 40% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Catheter in the event-volume neighbourhood

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

reports

What this shows Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days carries 48,999 MAUDE reports, ranked #72 of 1000.

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

Event Types

Malfunction 40,892 (83.5%)
Injury 6,441 (13.1%)
Other 1,290 (2.6%)
234 (0.5%)
Death 141 (0.3%)
No answer provided 1 (0.0%)

Patient Outcomes

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

30,895 (62.4%)
Other 12,529 (25.3%)
Required Intervention 4,601 (9.3%)
R 488 (1.0%)
Hospitalization 444 (0.9%)
Death 142 (0.3%)
Life Threatening 124 (0.3%)
O 90 (0.2%)
Disability 72 (0.1%)
L 48 (0.1%)
H 29 (0.1%)
S 15 (0.0%)
Invalid Data 9 (0.0%)
Congenital Anomaly 2 (0.0%)
D 1 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Leak/Splash 10,495
Break 5,354
Retraction Problem 4,408
Fluid/Blood Leak 3,259
Device Contamination with Chemical or Other Material 2,897
Material Separation 2,067
Defective Component 1,268
Material Puncture/Hole 1,106
Crack 1,032
Material Deformation 970
Difficult to Remove 890
Adverse Event Without Identified Device or Use Problem 858
Material Twisted/Bent 837
Deformation Due to Compressive Stress 836
Unraveled Material 829
Detachment Of Device Component 783
Kinked 753
Material Split, Cut or Torn 708
Material Protrusion/Extrusion 685
Detachment of Device or Device Component 626

Yearly Trend

92
1992: 36
93
1993: 53
94
1994: 130
95
1995: 125
96
1996: 252
97
1997: 318
98
1998: 189
99
1999: 189
00
2000: 201
01
2001: 357
02
2002: 293
03
2003: 336
04
2004: 323
05
2005: 376
06
2006: 336
07
2007: 374
08
2008: 422
09
2009: 508
10
2010: 370
11
2011: 786
12
2012: 560
13
2013: 640
14
2014: 815
15
2015: 729
16
2016: 926
17
2017: 1,966
18
2018: 3,298
19
2019: 4,365
20
2020: 3,797
21
2021: 4,674
22
2022: 4,133
23
2023: 4,430
24
2024: 4,774
25
2025: 5,188
26
2026: 2,730

Reports in 2025 (5,188) held close to the prior two-year average of 4,602.

Related Entities for Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Event Locations

26,223 (53.5%)
I 16,524 (33.7%)
HOSPITAL 4,659 (9.5%)
NO INFORMATION 457 (0.9%)
OTHER 415 (0.8%)
HOME 170 (0.3%)
INVALID DATA 144 (0.3%)
OUTPATIENT TREATMENT FACILITY 143 (0.3%)
UNKNOWN 109 (0.2%)
NOT APPLICABLE 64 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 43 (0.1%)
AMBULATORY SURGICAL FACILITY 34 (0.1%)
NURSING HOME 8 (0.0%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
CLINIC - WALK IN, OTHER 2 (0.0%)
BLOOD BANK 1 (0.0%)
HOSPICE 1 (0.0%)

Compare BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. vs BECTON DICKINSON →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter: 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 (48,999 here).

Similar death-typed counts

Nearest other device types by death-typed report count (141 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter 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 Catheter; 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.