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2026 data FDA MAUDE openFDA FDA Class II

Gastrointestinal Tubes With Enteral Specific Connectors

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 §876.5980 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Gastrointestinal Tubes With Enteral Specifi… LIGHT-BOOK · MAUDE

#766 of 1000 · 732 reports · 2015–2026

  • BOOK 732 reports
  • RANK #766 of 1000
  • DEATH 23 death-typed
  • INJ 168 injury-typed
  • MALF 537 malfunction
  • SPAN 2015–2026
  • PEAK 2024: 110
  • PHOTO Carboxymethylcellulos…

Nearest event-volume peer: Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium (3 report gap)

Gastrointestinal Tubes With Enteral Specific Connectors sits #766 of 1000 among tracked device types with 732 MAUDE reports spanning 2015–2026. 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

Gastrointestinal Tubes With Enteral Specifi… carries 73.4% MALFUNCTION-coded reports, 8.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.1% corpus 1.5% · above corpus mean (+1.6 pp)
  • INJ 23.0% corpus 30.3% · below corpus mean (-7.3 pp)
  • MALF 73.4% corpus 64.8% · above corpus mean (+8.5 pp)

Lead product-problem code Detachment of Device or Device Component is 15% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 38% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Gastrointestinal Tubes With Enteral Specifi… in the event-volume neighbourhood

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

reports

What this shows Gastrointestinal Tubes With Enteral Specific Connectors carries 732 MAUDE reports, ranked #766 of 1000.

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

Event Types

Malfunction 537 (73.4%)
Injury 168 (23.0%)
Death 23 (3.1%)
2 (0.3%)
Other 2 (0.3%)

Patient Outcomes

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

488 (65.7%)
Other 91 (12.2%)
Required Intervention 68 (9.2%)
Life Threatening 45 (6.1%)
Death 19 (2.6%)
Hospitalization 14 (1.9%)
R 8 (1.1%)
O 6 (0.8%)
D 2 (0.3%)
L 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Detachment of Device or Device Component 90
Break 87
Fluid/Blood Leak 79
Adverse Event Without Identified Device or Use Problem 42
Device Dislodged or Dislocated 38
Obstruction of Flow 37
Leak/Splash 30
Fracture 26
Unintended Deflation 26
Material Separation 22
Device Operates Differently Than Expected 19
Crack 18
Difficult to Advance 16
Insufficient Device Problem Information 15
Complete Blockage 14
Material Integrity Problem 13
Difficult to Remove 12
Physical Resistance/Sticking 12
Material Rupture 11
Material Twisted/Bent 11

Yearly Trend

15
2015: 12
16
2016: 45
17
2017: 17
18
2018: 17
19
2019: 28
20
2020: 70
21
2021: 89
22
2022: 77
23
2023: 96
24
2024: 110
25
2025: 84
26
2026: 87

Reports in 2025 (84) held close to the prior two-year average of 103.

Related Entities for Gastrointestinal Tubes With Enteral Specific Connectors

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 197
COVIDIEN 117
CARDINAL HEALTH 111
MAQUET CRITICAL CARE AB 60
BOSTON SCIENTIFIC - MARLBOROUGH 27
UNK 10

Event Locations

443 (60.5%)
I 229 (31.3%)
HOSPITAL 41 (5.6%)
NO INFORMATION 17 (2.3%)
HOME 2 (0.3%)

Compare BOSTON SCIENTIFIC CORPORATION vs COVIDIEN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Gastrointestinal Tubes With Enteral Specifi…: 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 (732 here).

Carboxymethylcellulose Sodium Or Polyvinyl… 729 Handpiece, Direct Drive, Ac-Powered 736 Humidifier Nebulizer Kit 723 Pacemaker Lead Adaptor 741

Similar death-typed counts

Nearest other device types by death-typed report count (23 here), distinct from the volume row.

Cannula, Catheter 23 Electrode, Electrocardiograph 23 Regulator, Pressure, Gas Cylinder 23 Transducer, Ultrasonic, Diagnostic 23

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

Disclaimer: MAUDE figures for Gastrointestinal Tubes With Enteral Specifi… 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 Gastrointestinal Tubes With Enteral Specifi…; 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.