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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Tray LIGHT-BOOK · MAUDE

#738 of 1000 · 762 reports · 1992–2026

  • BOOK 762 reports
  • RANK #738 of 1000
  • DEATH 2 death-typed
  • INJ 93 injury-typed
  • MALF 658 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 86
  • PHOTO Table

Nearest event-volume peer: Table, Radiographic, Tilting (0 report gap)

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) sits #738 of 1000 among tracked device types with 762 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 (-1.3 pp)
  • INJ 12.2% corpus 30.4% · below corpus mean (-18.2 pp)
  • MALF 86.4% corpus 64.5% · above corpus mean (+21.8 pp)

Lead product-problem code Component Missing is 14% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 79% of manufacturer-tagged reports · Top event location is 54% 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 762 MAUDE reports, ranked #738 of 1000.

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

Event Types

Malfunction 658 (86.4%)
Injury 93 (12.2%)
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.

446 (57.8%)
Other 256 (33.2%)
Required Intervention 47 (6.1%)
Hospitalization 8 (1.0%)
R 7 (0.9%)
O 3 (0.4%)
Congenital Anomaly 2 (0.3%)
Death 2 (0.3%)
H 1 (0.1%)

Top Product Problems

Component Missing 71
Improper Chemical Reaction 54
Product Quality Problem 48
Difficult to Insert 38
Component Misassembled 34
Fluid/Blood Leak 28
Adverse Event Without Identified Device or Use Problem 26
Material Twisted/Bent 25
Unintended Deflation 22
Patient-Device Incompatibility 21
Nonstandard Device 20
Incorrect Measurement 19
Biocompatibility 18
Inaccurate Flow Rate 16
Gel Leak 15
Material Integrity Problem 15
Leak/Splash 13
Defective Device 12
Deflation Problem 12
Material Fragmentation 12

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: 7

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 40
COVIDIEN 30
CARDINAL HEALTH 28

Event Locations

414 (54.3%)
I 300 (39.4%)
HOSPITAL 33 (4.3%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Tray, 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 (762 here).

Table, Radiographic, Tilting 762 Electrosurgical 763 Support, Patient Position 761 Incubator, Neonatal 764

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 Analyzer, Chemistry Clinical Use 2 Bed, Pediatric Open Hospital 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.