2026 data FDA MAUDE openFDA FDA Class II

Catheter, Hemodialysis, Triple Lumen, Non-Implanted

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 §876.5540 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Catheter LIGHT-BOOK · MAUDE

#717 of 1000 · 825 reports · 2002–2026

  • BOOK 825 reports
  • RANK #717 of 1000
  • DEATH 26 death-typed
  • INJ 135 injury-typed
  • MALF 660 malfunction
  • SPAN 2002–2026
  • PEAK 2024: 125
  • PHOTO Suture

Nearest event-volume peer: Suture, Nonabsorbable, Synthetic, Polyester (0 report gap)

Catheter, Hemodialysis, Triple Lumen, Non-Implanted sits #717 of 1000 among tracked device types with 825 MAUDE reports spanning 2002–2026. 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 80.0% MALFUNCTION-coded reports, 15.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.2% corpus 1.5% · above corpus mean (+1.6 pp)
  • INJ 16.4% corpus 30.3% · below corpus mean (-13.9 pp)
  • MALF 80.0% corpus 64.8% · above corpus mean (+15.2 pp)

Lead product-problem code Fluid/Blood Leak is 16% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 58% of manufacturer-tagged reports · Top event location is 57% 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, Hemodialysis, Triple Lumen, Non-Implanted carries 825 MAUDE reports, ranked #717 of 1000.

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

Event Types

Malfunction 660 (80.0%)
Injury 135 (16.4%)
Death 26 (3.2%)
2 (0.2%)
Other 2 (0.2%)

Patient Outcomes

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

402 (48.3%)
Other 258 (31.0%)
Required Intervention 131 (15.7%)
Death 28 (3.4%)
O 6 (0.7%)
R 3 (0.4%)
Life Threatening 3 (0.4%)
H 1 (0.1%)
Hospitalization 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 117
Material Deformation 74
Break 69
Adverse Event Without Identified Device or Use Problem 64
Material Frayed 60
Obstruction of Flow 53
Difficult to Remove 35
Material Puncture/Hole 32
Defective Component 29
Detachment of Device or Device Component 22
Device Dislodged or Dislocated 22
Leak/Splash 21
Unraveled Material 21
Material Twisted/Bent 16
Product Quality Problem 16
Contamination /Decontamination Problem 14
Hole In Material 14
Physical Resistance/Sticking 14
Component Incompatible 13
Failure to Advance 12

Yearly Trend

02
2002: 1
06
2006: 1
08
2008: 2
09
2009: 3
10
2010: 5
11
2011: 12
12
2012: 9
13
2013: 7
14
2014: 13
15
2015: 7
16
2016: 13
17
2017: 38
18
2018: 88
19
2019: 61
20
2020: 51
21
2021: 61
22
2022: 119
23
2023: 103
24
2024: 125
25
2025: 74
26
2026: 32

Reports fell to 74 in 2025, down from an average of 114 in the two years before.

Related Entities for Catheter, Hemodialysis, Triple Lumen, Non-Implanted

Event Locations

474 (57.5%)
HOSPITAL 233 (28.2%)
I 110 (13.3%)
NO INFORMATION 7 (0.8%)
OTHER 1 (0.1%)

Compare C.R. BARD, INC. (BASD) -3006260740 vs BARD ACCESS SYSTEMS →

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 (825 here).

Similar death-typed counts

Nearest other device types by death-typed report count (26 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.