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 Class II (moderate risk, special controls required), regulated under 21 CFR §876.5820 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Set LIGHT-BOOK · MAUDE
#245 of 1000 · 8,011 reports · 1992–2026
- BOOK 8,011 reports
- RANK #245 of 1000
- DEATH 307 death-typed
- INJ 1,500 injury-typed
- MALF 6,043 malfunction
- SPAN 1992–2026
- PEAK 2025: 1,494
- PHOTO Lens
Nearest event-volume peer: Lens, Intraocular, Toric Optics (12 report gap)
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve sits #245 of 1000 among tracked device types with 8,011 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 sit below the device-type norm
Set carries 18.7% INJURY-coded reports, 11.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 3.8% corpus 1.5% · above corpus mean (+2.3 pp)
- INJ 18.7% corpus 30.3% · below corpus mean (-11.6 pp)
- MALF 75.4% corpus 64.8% · above corpus mean (+10.6 pp)
Lead product-problem code Fluid/Blood Leak is 21% of coded problems · Lead manufacturer B. BRAUN MEDICAL INC. accounts for 52% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .
Set in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Dermatome
Dermatome
8,121 reports
- Prosthesis
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
8,110 reports
- Accessories
Accessories, Soft Lens Products
8,031 reports
- Set (this)
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
8,011 reports
- Lens
Lens, Intraocular, Toric Optics
7,999 reports
- Catheter
Catheter, Ultrasound, Intravascular
7,853 reports
What this shows Set, Tubing, Blood, With And Without Anti-Regurgitation Valve carries 8,011 MAUDE reports, ranked #245 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 1,494 in 2025, up from an average of 501 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Top Manufacturers
Event Locations
Compare B. BRAUN MEDICAL INC. vs ERIKA DE REYNOSA, S.A. DE C.V. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Set: 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 (8,011 here).
Similar death-typed counts
Nearest other device types by death-typed report count (307 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.