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2026 data FDA MAUDE openFDA FDA Class I

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4200 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Needle, Catheter LIGHT-BOOK · MAUDE

#975 of 1000 · 394 reports · 1992–2026

  • BOOK 394 reports
  • RANK #975 of 1000
  • DEATH 5 death-typed
  • INJ 136 injury-typed
  • MALF 242 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 72
  • PHOTO Alkaline Picrate

Nearest event-volume peer: Alkaline Picrate, Colorimetry, Creatinine (0 report gap)

Needle, Catheter sits #975 of 1000 among tracked device types with 394 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 →

Injury-coded reports run above the device-type norm

Needle, Catheter carries 34.5% INJURY-coded reports, 4.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 34.5% corpus 30.3% · above corpus mean (+4.2 pp)
  • MALF 61.4% corpus 64.8% · below corpus mean (-3.4 pp)

Lead product-problem code Break is 18% of coded problems · Lead manufacturer COOK INC accounts for 28% of manufacturer-tagged reports · Top event location I is 43% 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 394 MAUDE reports, ranked #975 of 1000.

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

Event Types

Malfunction 242 (61.4%)
Injury 136 (34.5%)
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

Break 74
Material Separation 65
Leak/Splash 46
Fracture 35
Detachment of Device or Device Component 23
Device, or device fragments remain in patient 21
Difficult to Remove 20
Detachment Of Device Component 18
Material Rupture 18
Air Leak 17
Adverse Event Without Identified Device or Use Problem 15
Material Split, Cut or Torn 11
Crack 10
Fluid/Blood Leak 9
Component(s), broken 8
Tip breakage 8
Device, removal of (non-implant) 7
Defective Device 6
Replace 6
Component Missing 5

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: 3

Reports rose to 16 in 2025, up from an average of 11 in the two years before - a recent-year increase, not a lifetime pattern.

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 (43.4%)
162 (41.1%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Needle, Catheter: 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 (394 here).

Alkaline Picrate, Colorimetry, Creatinine 394 Perforator, Ear-Lobe 393 Accessories, Catheter, G-U 392 Controller, Foot, Handpiece And Cord 392

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.