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2026 data FDA MAUDE openFDA FDA Class II

Tubing, Fluid Delivery

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 §880.5440 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Tubing, Fluid Delivery LIGHT-BOOK · MAUDE

#710 of 1000 · 850 reports · 1992–2026

  • BOOK 850 reports
  • RANK #710 of 1000
  • DEATH 5 death-typed
  • INJ 33 injury-typed
  • MALF 798 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 112
  • PHOTO Posterior Metal/Polym…

Nearest event-volume peer: Posterior Metal/Polymer Spinal System, Fusion (2 report gap)

Tubing, Fluid Delivery sits #710 of 1000 among tracked device types with 850 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

Tubing, Fluid Delivery carries 93.9% MALFUNCTION-coded reports, 29.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 3.9% corpus 30.3% · below corpus mean (-26.4 pp)
  • MALF 93.9% corpus 64.8% · above corpus mean (+29.1 pp)

Lead product-problem code Fluid/Blood Leak is 19% of coded problems · Lead manufacturer MERIT MEDICAL SYSTEMS, INC. accounts for 50% of manufacturer-tagged reports · Top event location is 84% of location-tagged rows .

Tubing, Fluid Delivery in the event-volume neighbourhood

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

reports

What this shows Tubing, Fluid Delivery carries 850 MAUDE reports, ranked #710 of 1000.

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

Event Types

Malfunction 798 (93.9%)
Injury 33 (3.9%)
Other 10 (1.2%)
Death 5 (0.6%)
4 (0.5%)

Patient Outcomes

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

707 (82.0%)
Other 79 (9.2%)
Required Intervention 51 (5.9%)
R 7 (0.8%)
Death 5 (0.6%)
Life Threatening 4 (0.5%)
Hospitalization 3 (0.3%)
O 2 (0.2%)
H 1 (0.1%)
L 1 (0.1%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 164
Disconnection 107
Leak/Splash 85
Failure to Deliver 83
Break 78
Material Separation 72
Air Leak 48
Material Rupture 37
Valve(s), failure of 34
Crack 23
Detachment Of Device Component 23
No Flow 18
Replace 17
Spillage, accidental 17
Defective Component 15
Loose 11
Component(s), broken 10
Device Operates Differently Than Expected 10
Bubble(s) 8
Loose or Intermittent Connection 8

Yearly Trend

92
1992: 4
93
1993: 1
96
1996: 1
00
2000: 19
01
2001: 38
02
2002: 2
03
2003: 15
04
2004: 13
05
2005: 41
06
2006: 13
07
2007: 29
08
2008: 78
09
2009: 92
10
2010: 67
11
2011: 112
12
2012: 108
13
2013: 29
14
2014: 31
15
2015: 15
16
2016: 12
17
2017: 15
18
2018: 9
19
2019: 10
20
2020: 4
21
2021: 8
22
2022: 7
23
2023: 15
24
2024: 8
25
2025: 30
26
2026: 24

Reports rose to 30 in 2025, up from an average of 12 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Tubing, Fluid Delivery

Top Manufacturers

MERIT MEDICAL SYSTEMS, INC. 93
HOSPIRA COSTA RICA LTD. 65
SMITHS MEDICAL ASD, INC. 28

Event Locations

718 (84.5%)
HOSPITAL 62 (7.3%)
I 53 (6.2%)
NO INFORMATION 7 (0.8%)
OUTPATIENT TREATMENT FACILITY 5 (0.6%)
UNKNOWN 3 (0.4%)
INVALID DATA 1 (0.1%)
OTHER 1 (0.1%)

Compare MERIT MEDICAL SYSTEMS, INC. vs HOSPIRA COSTA RICA LTD. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tubing, Fluid Delivery: 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 (850 here).

Posterior Metal/Polymer Spinal System 848 Dislodger, Stone, Biliary 847 Incubator, Neonatal 847 Instruments, Surgical, Cardiovascular 845

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 Tubing, Fluid Delivery 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 Tubing, Fluid Delivery; 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.