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2026 data FDA MAUDE openFDA

Catheter, Hemodialysis, 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.

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FDA MAUDE casebook

openFDA event book Catheter, Hemodialysis, Non-Implanted LIGHT-BOOK · MAUDE

#378 of 1000 · 3,144 reports · 1995–2026

  • BOOK 3,144 reports
  • RANK #378 of 1000
  • DEATH 72 death-typed
  • INJ 600 injury-typed
  • MALF 2,376 malfunction
  • SPAN 1995–2026
  • PEAK 2000: 285
  • PHOTO Accessories

Nearest event-volume peer: Accessories, Implant, Dental, Endosseous (8 report gap)

Catheter, Hemodialysis, Non-Implanted sits #378 of 1000 among tracked device types with 3,144 MAUDE reports spanning 1995–2026. 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 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
  • INJ 19.1% corpus 30.4% · below corpus mean (-11.4 pp)
  • MALF 75.6% corpus 64.5% · above corpus mean (+11.1 pp)

Lead product-problem code Material Puncture/Hole is 13% of coded problems · Lead manufacturer COVIDIEN accounts for 30% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Catheter, Hemodialysis, Non-Implanted in the event-volume neighbourhood

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

reports

What this shows Catheter, Hemodialysis, Non-Implanted carries 3,144 MAUDE reports, ranked #378 of 1000.

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

Event Types

Malfunction 2,376 (75.6%)
Injury 600 (19.1%)
Death 72 (2.3%)
Other 68 (2.2%)
27 (0.9%)
No answer provided 1 (0.0%)

Patient Outcomes

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

1,837 (56.5%)
Required Intervention 729 (22.4%)
Other 414 (12.7%)
R 71 (2.2%)
Death 66 (2.0%)
Hospitalization 61 (1.9%)
Life Threatening 34 (1.0%)
O 16 (0.5%)
L 15 (0.5%)
D 3 (0.1%)
H 3 (0.1%)
Disability 3 (0.1%)
Congenital Anomaly 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Material Puncture/Hole 191
Break 141
Material Deformation 130
Difficult to Remove 123
Unraveled Material 103
Fluid/Blood Leak 102
Material Frayed 95
Material Twisted/Bent 81
Product Quality Problem 81
Deformation Due to Compressive Stress 66
Crack 65
Physical Resistance/Sticking 51
Leak/Splash 50
Obstruction of Flow 37
Material Separation 35
Adverse Event Without Identified Device or Use Problem 34
Kinked 34
Detachment of Device or Device Component 31
Migration or Expulsion of Device 27
Component Incompatible 24

Yearly Trend

95
1995: 1
97
1997: 9
98
1998: 64
99
1999: 114
00
2000: 285
01
2001: 107
02
2002: 81
03
2003: 43
04
2004: 21
05
2005: 25
06
2006: 35
07
2007: 41
08
2008: 147
09
2009: 166
10
2010: 60
11
2011: 74
12
2012: 78
13
2013: 124
14
2014: 82
15
2015: 51
16
2016: 70
17
2017: 86
18
2018: 120
19
2019: 119
20
2020: 179
21
2021: 192
22
2022: 166
23
2023: 203
24
2024: 181
25
2025: 191
26
2026: 29

Related Entities for Catheter, Hemodialysis, Non-Implanted

Top Manufacturers

COVIDIEN 467
BARD ACCESS SYSTEMS 381
C.R. BARD, INC. (BASD) -3006260740 257
ARROW INTERNATIONAL LLC 238
ARROW INTERNATIONAL INC. 192

Event Locations

1,382 (44.0%)
HOSPITAL 930 (29.6%)
I 542 (17.2%)
UNKNOWN 114 (3.6%)
OUTPATIENT TREATMENT FACILITY 70 (2.2%)
OTHER 42 (1.3%)
HOME 26 (0.8%)
NO INFORMATION 13 (0.4%)
INVALID DATA 11 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 8 (0.3%)
NURSING HOME 3 (0.1%)
DIALYSIS UNIT 2 (0.1%)
DIALYSIS CENTER 1 (0.0%)

Compare COVIDIEN vs BARD ACCESS SYSTEMS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Hemodialysis, Non-Implanted, 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 (3,144 here).

Accessories, Implant, Dental, Endosseous 3,152 Scaler, Ultrasonic 3,134 System 3,131 Apparatus, Autotransfusion 3,115

Similar death-typed counts

Nearest other device types by death-typed report count (72 here), distinct from the volume row.

Catheter, Ultrasound, Intravascular 72 Intestinal Stimulator 72 Prosthesis 72 Ligator, Esophageal 71

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

Disclaimer: MAUDE figures for Catheter, Hemodialysis, Non-Implanted 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, Hemodialysis, Non-Implanted; 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.