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2026 data FDA MAUDE openFDA FDA Class II

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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 Tray LIGHT-BOOK · MAUDE

#734 of 1000 · 800 reports · 1992–2026

  • BOOK 800 reports
  • RANK #734 of 1000
  • DEATH 2 death-typed
  • INJ 97 injury-typed
  • MALF 692 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 86
  • PHOTO Heparin

Nearest event-volume peer: Heparin, Vascular Access Flush (0 report gap)

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) sits #734 of 1000 among tracked device types with 800 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

Tray carries 86.5% MALFUNCTION-coded reports, 21.7pp 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 (-1.3 pp)
  • INJ 12.1% corpus 30.3% · below corpus mean (-18.2 pp)
  • MALF 86.5% corpus 64.8% · above corpus mean (+21.7 pp)

Lead product-problem code Component Missing is 13% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 77% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Tray in the event-volume neighbourhood

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

reports

What this shows Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) carries 800 MAUDE reports, ranked #734 of 1000.

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

Event Types

Malfunction 692 (86.5%)
Injury 97 (12.1%)
Other 6 (0.8%)
3 (0.4%)
Death 2 (0.3%)

Patient Outcomes

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

466 (57.5%)
Other 274 (33.8%)
Required Intervention 47 (5.8%)
Hospitalization 8 (1.0%)
R 7 (0.9%)
O 3 (0.4%)
Congenital Anomaly 2 (0.2%)
Death 2 (0.2%)
H 1 (0.1%)

Top Product Problems

Component Missing 82
Improper Chemical Reaction 54
Product Quality Problem 53
Leak/Splash 52
Difficult to Insert 48
Fluid/Blood Leak 36
Component Misassembled 34
Material Twisted/Bent 31
Nonstandard Device 28
Difficult to Remove 27
Adverse Event Without Identified Device or Use Problem 26
Packaging Problem 22
Unintended Deflation 22
Partial Blockage 21
Patient-Device Incompatibility 21
Inaccurate Flow Rate 20
Incorrect Measurement 20
Bent 19
Deflation Problem 19
Biocompatibility 18

Yearly Trend

92
1992: 7
93
1993: 2
94
1994: 3
99
1999: 1
01
2001: 56
02
2002: 54
03
2003: 30
04
2004: 11
07
2007: 1
08
2008: 3
09
2009: 6
10
2010: 3
11
2011: 4
12
2012: 3
13
2013: 4
14
2014: 6
15
2015: 5
16
2016: 14
17
2017: 33
18
2018: 61
19
2019: 79
20
2020: 86
21
2021: 85
22
2022: 59
23
2023: 48
24
2024: 54
25
2025: 37
26
2026: 45

Reports in 2025 (37) held close to the prior two-year average of 51.

Related Entities for Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 378
C.R. BARD INC. (COVINGTON) -1018233 58
COVIDIEN 30
CARDINAL HEALTH 28

Event Locations

452 (56.5%)
I 300 (37.5%)
HOSPITAL 33 (4.1%)
NO INFORMATION 7 (0.9%)
INVALID DATA 4 (0.5%)
OTHER 2 (0.3%)
HOME 1 (0.1%)
NURSING HOME 1 (0.1%)

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 Tray: 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 (800 here).

Heparin, Vascular Access Flush 800 Humidifier, Non-Direct Patient Interface 801 Electrode, Electrosurgical 798 Drape, Surgical, Antimicrobial 803

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Tray 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 Tray; 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.