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2026 data FDA MAUDE openFDA FDA Class II

Catheter, Urological (Antimicrobial) And Accessories

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 §876.5130 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Catheter, Urological And Accessories MID-BOOK · MAUDE

#169 of 1000 · 16,326 reports · 1996–2026

  • BOOK 16,326 reports
  • RANK #169 of 1000
  • DEATH 1 death-typed
  • INJ 633 injury-typed
  • MALF 15,683 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 3,809
  • PHOTO Endoscopic Ultrasound…

Nearest event-volume peer: Endoscopic Ultrasound System, Gastroenterology-Urology (5 report gap)

Catheter, Urological (Antimicrobial) And Accessories sits #169 of 1000 among tracked device types with 16,326 MAUDE reports spanning 1996–2026. 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, Urological And Accessories carries 96.1% MALFUNCTION-coded reports, 31.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.9% corpus 30.3% · below corpus mean (-26.4 pp)
  • MALF 96.1% corpus 64.8% · above corpus mean (+31.2 pp)

Lead product-problem code Material Puncture/Hole is 20% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 70% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

Catheter, Urological And Accessories in the event-volume neighbourhood

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

reports

What this shows Catheter, Urological (Antimicrobial) And Accessories carries 16,326 MAUDE reports, ranked #169 of 1000.

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

Event Types

Malfunction 15,683 (96.1%)
Injury 633 (3.9%)
Other 5 (0.0%)
4 (0.0%)
Death 1 (0.0%)

Patient Outcomes

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

Other 12,081 (73.9%)
3,691 (22.6%)
Required Intervention 464 (2.8%)
R 42 (0.3%)
O 34 (0.2%)
Hospitalization 18 (0.1%)
H 5 (0.0%)
Life Threatening 3 (0.0%)
D 1 (0.0%)
L 1 (0.0%)
S 1 (0.0%)
Death 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Material Puncture/Hole 3,590
Fluid/Blood Leak 2,149
Deflation Problem 2,145
Difficult to Remove 1,398
Decrease in Pressure 1,268
Failure to Infuse 1,169
Material Rupture 933
Burst Container or Vessel 821
Inflation Problem 800
Material Split, Cut or Torn 548
Material Fragmentation 420
Inaccurate Flow Rate 411
Component Misassembled 394
Break 365
Leak/Splash 338
Device Contamination with Chemical or Other Material 270
Component Missing 269
Material Twisted/Bent 249
Short Fill 222
Disconnection 203

Yearly Trend

96
1996: 2
09
2009: 2
10
2010: 1
12
2012: 5
13
2013: 8
14
2014: 13
15
2015: 25
16
2016: 134
17
2017: 714
18
2018: 613
19
2019: 1,270
20
2020: 1,433
21
2021: 1,464
22
2022: 1,796
23
2023: 1,987
24
2024: 1,960
25
2025: 3,809
26
2026: 1,090

Reports rose to 3,809 in 2025, up from an average of 1,974 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Urological (Antimicrobial) And Accessories

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 10,870
C.R. BARD INC. (COVINGTON) -1018233 4,667
C.R. Bard Inc. (Covington) -1018233 53

Event Locations

11,185 (68.5%)
I 4,893 (30.0%)
HOSPITAL 189 (1.2%)
NO INFORMATION 53 (0.3%)
OTHER 5 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs C.R. BARD INC. (COVINGTON) -1018233 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Urological And Accessories: 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 (16,326 here).

Endoscopic Ultrasound System 16,331 Prosthesis 16,332 Cardiac Ablation Percutaneous Catheter 16,442 Prosthesis 16,505

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Catheter, Urological And Accessories 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, Urological And Accessories; 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.