2026 data FDA MAUDE openFDA

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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 MAUDE casebook

openFDA event book Set LIGHT-BOOK · MAUDE

#254 of 1000 · 7,136 reports · 1992–2026

  • BOOK 7,136 reports
  • RANK #254 of 1000
  • DEATH 307 death-typed
  • INJ 1,482 injury-typed
  • MALF 5,189 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,494
  • PHOTO System

Nearest event-volume peer: System, X-Ray, Angiographic (9 report gap)

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve sits #254 of 1000 among tracked device types with 7,136 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 4.3% corpus 1.5% · above corpus mean (+2.8 pp)
  • INJ 20.8% corpus 30.4% · below corpus mean (-9.7 pp)
  • MALF 72.7% corpus 64.5% · above corpus mean (+8.2 pp)

Lead product-problem code Air/Gas in Device is 34% of coded problems · Lead manufacturer B. BRAUN MEDICAL INC. accounts for 58% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Set in the event-volume neighbourhood

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

reports

What this shows Set, Tubing, Blood, With And Without Anti-Regurgitation Valve carries 7,136 MAUDE reports, ranked #254 of 1000.

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

Event Types

Malfunction 5,189 (72.7%)
Injury 1,482 (20.8%)
Death 307 (4.3%)
Other 122 (1.7%)
36 (0.5%)

Patient Outcomes

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

4,740 (60.2%)
Other 1,074 (13.6%)
Hospitalization 562 (7.1%)
Required Intervention 393 (5.0%)
R 391 (5.0%)
Death 285 (3.6%)
L 194 (2.5%)
O 90 (1.1%)
Life Threatening 74 (0.9%)
H 55 (0.7%)
S 8 (0.1%)
D 5 (0.1%)
Disability 5 (0.1%)
Invalid Data 1 (0.0%)

Top Product Problems

Air/Gas in Device 1,596
Fluid/Blood Leak 1,240
Leak/Splash 777
Detachment of Device or Device Component 274
Material Puncture/Hole 207
Adverse Event Without Identified Device or Use Problem 131
Crack 84
Loose or Intermittent Connection 80
Disconnection 64
Obstruction of Flow 63
Device Alarm System 57
Contamination /Decontamination Problem 35
Break 28
Connection Problem 24
Material Deformation 21
Insufficient Information 19
Degraded 18
Occlusion Within Device 16
Air Leak 15
Defective Device 15

Yearly Trend

92
1992: 3
93
1993: 14
94
1994: 20
95
1995: 30
96
1996: 215
97
1997: 142
98
1998: 372
99
1999: 269
00
2000: 154
01
2001: 63
02
2002: 76
03
2003: 148
04
2004: 131
05
2005: 141
06
2006: 203
07
2007: 135
08
2008: 86
09
2009: 76
10
2010: 130
11
2011: 243
12
2012: 35
13
2013: 114
14
2014: 116
15
2015: 126
16
2016: 139
17
2017: 131
18
2018: 119
19
2019: 185
20
2020: 190
21
2021: 188
22
2022: 362
23
2023: 585
24
2024: 417
25
2025: 1,494
26
2026: 284

Related Entities for Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Event Locations

4,395 (61.6%)
I 820 (11.5%)
OUTPATIENT TREATMENT FACILITY 722 (10.1%)
HOSPITAL 440 (6.2%)
OTHER 363 (5.1%)
INVALID DATA 115 (1.6%)
DIALYSIS CENTER 87 (1.2%)
NO INFORMATION 58 (0.8%)
HOME 39 (0.5%)
DIALYSIS UNIT 38 (0.5%)
NOT APPLICABLE 18 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 18 (0.3%)
UNKNOWN 14 (0.2%)
AMBULATORY SURGICAL FACILITY 5 (0.1%)
NURSING HOME 3 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)

Compare B. BRAUN MEDICAL INC. vs ERIKA DE REYNOSA, S.A. DE C.V. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Set, 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 (7,136 here).

Similar death-typed counts

Nearest other device types by death-typed report count (307 here), distinct from the volume row.

Disclaimer: MAUDE figures for Set 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 Set; 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.