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2026 data FDA MAUDE openFDA FDA Class I

Holder, Ureteral Catheter

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §876.5130 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Holder, Ureteral Catheter LIGHT-BOOK · MAUDE

#630 of 1000 · 1,177 reports · 1992–2026

  • BOOK 1,177 reports
  • RANK #630 of 1000
  • DEATH 0 death-typed
  • INJ 60 injury-typed
  • MALF 1,114 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 234
  • PHOTO Spinal Pedicle Screw

Nearest event-volume peer: Spinal Pedicle Screw, Fixation, Appliance System (1 report gap)

Holder, Ureteral Catheter sits #630 of 1000 among tracked device types with 1,177 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

Holder, Ureteral Catheter carries 94.6% MALFUNCTION-coded reports, 29.8pp 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 5.1% corpus 30.3% · below corpus mean (-25.2 pp)
  • MALF 94.6% corpus 64.8% · above corpus mean (+29.8 pp)

Lead product-problem code Disconnection is 36% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 97% of manufacturer-tagged reports · Top event location I is 69% of location-tagged rows .

Holder, Ureteral Catheter in the event-volume neighbourhood

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

reports

What this shows Holder, Ureteral Catheter carries 1,177 MAUDE reports, ranked #630 of 1000.

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

Event Types

Malfunction 1,114 (94.6%)
Injury 60 (5.1%)
Other 2 (0.2%)
1 (0.1%)

Patient Outcomes

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

633 (53.4%)
Other 510 (43.0%)
Required Intervention 27 (2.3%)
R 8 (0.7%)
O 3 (0.3%)
Disability 3 (0.3%)
Hospitalization 1 (0.1%)
Invalid Data 1 (0.1%)

Top Product Problems

Disconnection 488
Loss of or Failure to Bond 186
Difficult to Open or Close 121
Fitting Problem 103
Material Fragmentation 85
Detachment of Device or Device Component 57
Break 48
Device Slipped 37
Failure To Adhere Or Bond 31
Nonstandard Device 30
Device Operates Differently Than Expected 26
Loose or Intermittent Connection 26
Material Separation 25
Detachment Of Device Component 21
Adverse Event Without Identified Device or Use Problem 15
Patient-Device Incompatibility 15
Component Falling 14
Patient Device Interaction Problem 14
Mechanical Problem 13
Device Fell 10

Yearly Trend

92
1992: 2
93
1993: 3
95
1995: 4
00
2000: 1
05
2005: 3
10
2010: 1
13
2013: 2
14
2014: 3
15
2015: 2
16
2016: 2
17
2017: 117
18
2018: 182
19
2019: 157
20
2020: 234
21
2021: 176
22
2022: 118
23
2023: 98
24
2024: 43
25
2025: 21
26
2026: 8

Reports fell to 21 in 2025, down from an average of 71 in the two years before.

Related Entities for Holder, Ureteral Catheter

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 1,072
C.R. BARD INC. (COVINGTON) -1018233 32
MEDLINE INDUSTRIES LP 4

Event Locations

I 807 (68.6%)
346 (29.4%)
HOSPITAL 18 (1.5%)
NO INFORMATION 3 (0.3%)
INVALID DATA 2 (0.2%)
OTHER 1 (0.1%)

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

Nationwide devices with a comparable report-volume footprint

Holder, Ureteral Catheter carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,177 here).

Spinal Pedicle Screw 1,178 Endovascular Suturing System 1,181 Bed, Flotation Therapy, Powered 1,182 System, Monitoring, Perinatal 1,183

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Holder, Ureteral Catheter 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 Holder, Ureteral Catheter; 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.