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2026 data FDA MAUDE openFDA

Needle, 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.

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FDA MAUDE casebook

openFDA event book Needle, Catheter LIGHT-BOOK · MAUDE

#958 of 1000 · 392 reports · 1992–2026

  • BOOK 392 reports
  • RANK #958 of 1000
  • DEATH 5 death-typed
  • INJ 135 injury-typed
  • MALF 241 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 72
  • PHOTO Coagulator-Cutter

Nearest event-volume peer: Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) (1 report gap)

Needle, Catheter sits #958 of 1000 among tracked device types with 392 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 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 34.4% corpus 30.4% · above corpus mean (+4.0 pp)
  • MALF 61.5% corpus 64.5% · below corpus mean (-3.0 pp)

Lead product-problem code Material Separation is 18% of coded problems · Lead manufacturer COOK INC accounts for 28% of manufacturer-tagged reports · Top event location I is 44% of location-tagged rows .

Needle, Catheter in the event-volume neighbourhood

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

reports

What this shows Needle, Catheter carries 392 MAUDE reports, ranked #958 of 1000.

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

Event Types

Malfunction 241 (61.5%)
Injury 135 (34.4%)
Other 6 (1.5%)
5 (1.3%)
Death 5 (1.3%)

Patient Outcomes

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

151 (35.9%)
Other 127 (30.2%)
Required Intervention 95 (22.6%)
R 22 (5.2%)
Hospitalization 8 (1.9%)
Life Threatening 6 (1.4%)
Death 5 (1.2%)
H 3 (0.7%)
O 3 (0.7%)
L 1 (0.2%)

Top Product Problems

Material Separation 48
Leak/Splash 38
Break 37
Fracture 34
Detachment of Device or Device Component 22
Material Rupture 18
Adverse Event Without Identified Device or Use Problem 15
Material Split, Cut or Torn 11
Difficult to Remove 8
Air Leak 4
Fluid/Blood Leak 4
Crack 3
Defective Component 3
Detachment Of Device Component 3
Device Fell 3
Entrapment of Device 3
Material Deformation 3
Material Fragmentation 3
Material Integrity Problem 3
Nonstandard Device 3

Yearly Trend

92
1992: 3
94
1994: 1
95
1995: 1
97
1997: 2
98
1998: 4
99
1999: 3
00
2000: 1
01
2001: 7
02
2002: 11
03
2003: 10
04
2004: 11
05
2005: 7
06
2006: 11
07
2007: 7
08
2008: 4
09
2009: 1
10
2010: 8
11
2011: 11
12
2012: 5
13
2013: 13
14
2014: 11
15
2015: 9
16
2016: 9
17
2017: 19
18
2018: 25
19
2019: 46
20
2020: 72
21
2021: 19
22
2022: 23
23
2023: 14
24
2024: 7
25
2025: 16
26
2026: 1

Related Entities for Needle, Catheter

Top Manufacturers

COOK INC 61
CAREFUSION, INC 59
CAREFUSION 44
CARDINAL HEALTH 42
ABBOTT LABORATORIES 14

Event Locations

I 171 (43.6%)
160 (40.8%)
HOSPITAL 53 (13.5%)
NO INFORMATION 4 (1.0%)
INVALID DATA 2 (0.5%)
OTHER 1 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.3%)

Compare COOK INC vs CAREFUSION, INC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Needle, Catheter, 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 (392 here).

Coagulator-Cutter, Endoscopic, Unipolar 391 Fibrin Sealant Preparation Device 393 Perforator, Ear-Lobe 393 Accessories, Catheter, G-U 390

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

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

Disclaimer: MAUDE figures for Needle, 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 Needle, 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.