2026 data FDA MAUDE openFDA FDA Class II

Catheter Care Tray

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).

FDA MAUDE casebook

openFDA event book Catheter Care Tray LIGHT-BOOK · MAUDE

#680 of 1000 · 944 reports · 2014–2026

  • BOOK 944 reports
  • RANK #680 of 1000
  • DEATH 1 death-typed
  • INJ 387 injury-typed
  • MALF 555 malfunction
  • SPAN 2014–2026
  • PEAK 2022: 167
  • PHOTO Plate

Nearest event-volume peer: Plate, Cranioplasty, Preformed, Alterable (0 report gap)

Catheter Care Tray sits #680 of 1000 among tracked device types with 944 MAUDE reports spanning 2014–2026. 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 →

Injury-coded reports run above the device-type norm

Catheter Care Tray carries 41.0% INJURY-coded reports, 10.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 41.0% corpus 30.3% · above corpus mean (+10.7 pp)
  • MALF 58.8% corpus 64.8% · below corpus mean (-6.0 pp)

Lead product-problem code Sharp Edges is 11% of coded problems · Lead manufacturer MEDLINE INDUSTRIES, LP accounts for 51% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .

Catheter Care Tray in the event-volume neighbourhood

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

reports

What this shows Catheter Care Tray carries 944 MAUDE reports, ranked #680 of 1000.

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

Event Types

Malfunction 555 (58.8%)
Injury 387 (41.0%)
Death 1 (0.1%)
Other 1 (0.1%)

Patient Outcomes

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

Other 560 (58.9%)
263 (27.7%)
Required Intervention 115 (12.1%)
R 6 (0.6%)
O 3 (0.3%)
Hospitalization 2 (0.2%)
S 1 (0.1%)
Death 1 (0.1%)

Top Product Problems

Sharp Edges 92
Appropriate Device Problem Term/Code Not Available 87
Material Integrity Problem 86
Fluid/Blood Leak 76
Component Missing 69
Leak/Splash 67
Break 60
Material Rupture 48
Inflation Problem 45
Deflation Problem 28
Obstruction of Flow 25
Detachment of Device or Device Component 22
Burst Container or Vessel 21
Device Dislodged or Dislocated 20
Adverse Event Without Identified Device or Use Problem 17
Unintended Deflation 16
Connection Problem 14
Material Puncture/Hole 14
Insufficient Device Problem Information 13
Material Split, Cut or Torn 13

Yearly Trend

14
2014: 1
15
2015: 11
16
2016: 25
17
2017: 25
18
2018: 34
19
2019: 63
20
2020: 22
21
2021: 48
22
2022: 167
23
2023: 144
24
2024: 162
25
2025: 152
26
2026: 90

Reports in 2025 (152) held close to the prior two-year average of 153.

Related Entities for Catheter Care Tray

Event Locations

721 (76.4%)
I 165 (17.5%)
HOSPITAL 44 (4.7%)
NO INFORMATION 6 (0.6%)
OTHER 4 (0.4%)
AMBULATORY SURGICAL FACILITY 2 (0.2%)
HOME 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare MEDLINE INDUSTRIES, LP vs MEDLINE INDUSTRIES LP →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter Care 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 (944 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Catheter Care 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 Catheter Care 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.