2026 data FDA MAUDE openFDA FDA Class II

Catheter, Straight

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, Straight LIGHT-BOOK · MAUDE

#348 of 1000 · 4,229 reports · 1992–2026

  • BOOK 4,229 reports
  • RANK #348 of 1000
  • DEATH 6 death-typed
  • INJ 1,184 injury-typed
  • MALF 3,034 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 994
  • PHOTO Stretcher

Nearest event-volume peer: Stretcher, Wheeled, Powered (3 report gap)

Catheter, Straight sits #348 of 1000 among tracked device types with 4,229 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

Catheter, Straight carries 71.7% MALFUNCTION-coded reports, 6.9pp 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 28.0% corpus 30.3% · below corpus mean (-2.3 pp)
  • MALF 71.7% corpus 64.8% · above corpus mean (+6.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 18% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 93% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Catheter, Straight in the event-volume neighbourhood

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

reports

What this shows Catheter, Straight carries 4,229 MAUDE reports, ranked #348 of 1000.

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

Event Types

Malfunction 3,034 (71.7%)
Injury 1,184 (28.0%)
Death 6 (0.1%)
Other 3 (0.1%)
2 (0.0%)

Patient Outcomes

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

2,309 (53.1%)
Other 1,539 (35.4%)
Required Intervention 249 (5.7%)
Hospitalization 109 (2.5%)
R 73 (1.7%)
O 40 (0.9%)
H 13 (0.3%)
Death 6 (0.1%)
Life Threatening 3 (0.1%)
Disability 2 (0.0%)
L 1 (0.0%)
S 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 762
Defective Device 579
Product Quality Problem 510
Improper Chemical Reaction 391
Difficult to Insert 295
Sharp Edges 245
Difficult to Remove 178
Patient-Device Incompatibility 163
Incorrect Measurement 159
Biocompatibility 151
Material Integrity Problem 150
Material Twisted/Bent 130
Component Misassembled 123
Component Missing 93
Unsealed Device Packaging 79
Inaccurate Flow Rate 70
Device Damaged Prior to Use 68
Inadequacy of Device Shape and/or Size 66
Insufficient Device Problem Information 63
Tear, Rip or Hole in Device Packaging 61

Yearly Trend

92
1992: 1
94
1994: 1
99
1999: 3
00
2000: 1
01
2001: 2
03
2003: 1
04
2004: 1
09
2009: 4
10
2010: 6
11
2011: 4
12
2012: 2
13
2013: 18
14
2014: 17
15
2015: 21
16
2016: 21
17
2017: 120
18
2018: 390
19
2019: 466
20
2020: 563
21
2021: 994
22
2022: 487
23
2023: 553
24
2024: 116
25
2025: 291
26
2026: 146

Reports in 2025 (291) held close to the prior two-year average of 335.

Related Entities for Catheter, Straight

Event Locations

2,292 (54.2%)
I 1,912 (45.2%)
HOSPITAL 15 (0.4%)
NO INFORMATION 7 (0.2%)
HOME 2 (0.0%)
UNKNOWN 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, Straight: 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 (4,229 here).

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Straight 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, Straight; 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.