2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Catheter MID-BOOK · MAUDE

#71 of 1000 · 47,084 reports · 1992–2026

  • BOOK 47,084 reports
  • RANK #71 of 1000
  • DEATH 138 death-typed
  • INJ 6,285 injury-typed
  • MALF 39,136 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 5,188
  • PHOTO Tubes

Nearest event-volume peer: Tubes, Vials, Systems, Serum Separators, Blood Collection (862 report gap)

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days sits #71 of 1000 among tracked device types with 47,084 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 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 13.3% corpus 30.4% · below corpus mean (-17.1 pp)
  • MALF 83.1% corpus 64.5% · above corpus mean (+18.6 pp)

Lead product-problem code Leak/Splash is 28% of coded problems · Lead manufacturer BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. accounts for 39% of manufacturer-tagged reports · Top event location is 52% 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 47,084 MAUDE reports, ranked #71 of 1000.

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

Event Types

Malfunction 39,136 (83.1%)
Injury 6,285 (13.3%)
Other 1,290 (2.7%)
234 (0.5%)
Death 138 (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.

29,430 (61.7%)
Other 12,283 (25.8%)
Required Intervention 4,505 (9.5%)
R 484 (1.0%)
Hospitalization 438 (0.9%)
Death 140 (0.3%)
Life Threatening 122 (0.3%)
O 89 (0.2%)
Disability 72 (0.2%)
L 48 (0.1%)
H 23 (0.0%)
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 9,450
Break 3,855
Retraction Problem 3,836
Device Contamination with Chemical or Other Material 2,880
Fluid/Blood Leak 2,566
Material Separation 1,264
Defective Component 1,237
Material Puncture/Hole 920
Material Deformation 905
Deformation Due to Compressive Stress 825
Crack 797
Adverse Event Without Identified Device or Use Problem 754
Material Twisted/Bent 749
Material Split, Cut or Torn 678
Material Protrusion/Extrusion 652
Detachment of Device or Device Component 556
Unraveled Material 548
Physical Resistance/Sticking 479
Activation Problem 400
Contamination 393

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: 559
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: 816

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

Event Locations

24,400 (51.8%)
I 16,525 (35.1%)
HOSPITAL 4,573 (9.7%)
NO INFORMATION 457 (1.0%)
OTHER 413 (0.9%)
HOME 170 (0.4%)
INVALID DATA 144 (0.3%)
OUTPATIENT TREATMENT FACILITY 138 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, 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 (47,084 here).

Similar death-typed counts

Nearest other device types by death-typed report count (138 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.