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2026 data FDA MAUDE openFDA FDA Class II

Tubes, Vacuum Sample, With Anticoagulant

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 §862.1675 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Tubes, Vacuum Sample, With Anticoagulant LIGHT-BOOK · MAUDE

#507 of 1000 · 1,965 reports · 1999–2026

  • BOOK 1,965 reports
  • RANK #507 of 1000
  • DEATH 0 death-typed
  • INJ 6 injury-typed
  • MALF 1,958 malfunction
  • SPAN 1999–2026
  • PEAK 2025: 652
  • PHOTO Radioimmunoassay

Nearest event-volume peer: Radioimmunoassay, Total Triiodothyronine (14 report gap)

Tubes, Vacuum Sample, With Anticoagulant sits #507 of 1000 among tracked device types with 1,965 MAUDE reports spanning 1999–2026. 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

Tubes, Vacuum Sample, With Anticoagulant carries 99.6% MALFUNCTION-coded reports, 34.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.3% corpus 30.3% · below corpus mean (-30.0 pp)
  • MALF 99.6% corpus 64.8% · above corpus mean (+34.8 pp)

Lead product-problem code Short Fill is 30% of coded problems · Lead manufacturer BECTON, DICKINSON & CO. (BROKEN BOW) accounts for 54% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Tubes, Vacuum Sample, With Anticoagulant in the event-volume neighbourhood

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

reports

What this shows Tubes, Vacuum Sample, With Anticoagulant carries 1,965 MAUDE reports, ranked #507 of 1000.

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

Event Types

Malfunction 1,958 (99.6%)
Injury 6 (0.3%)
Other 1 (0.1%)

Patient Outcomes

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

1,436 (73.5%)
Other 514 (26.3%)
Required Intervention 5 (0.3%)

Top Product Problems

Short Fill 629
Device Contamination with Chemical or Other Material 296
Leak/Splash 203
Coagulation in Device or Device Ingredient 183
Volume Accuracy Problem 112
Improper Chemical Reaction 85
Incorrect, Inadequate or Imprecise Result or Readings 73
Device Markings/Labelling Problem 61
Material Protrusion/Extrusion 59
Clumping in Device or Device Ingredient 55
Material Deformation 51
Incorrect Or Inadequate Test Results 40
Premature Separation 37
Filling Problem 36
Device Ingredient or Reagent Problem 34
Difficult to Insert 32
Excessive Heating 31
Crack 22
Overfill 22
Fluid/Blood Leak 21

Yearly Trend

99
1999: 1
00
2000: 1
01
2001: 1
06
2006: 1
09
2009: 1
10
2010: 1
11
2011: 1
12
2012: 3
16
2016: 2
17
2017: 12
18
2018: 276
19
2019: 145
20
2020: 147
21
2021: 55
22
2022: 42
23
2023: 33
24
2024: 316
25
2025: 652
26
2026: 275

Reports rose to 652 in 2025, up from an average of 175 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Tubes, Vacuum Sample, With Anticoagulant

Top Manufacturers

BECTON, DICKINSON & CO. (BROKEN BOW) 857
BECTON, DICKINSON & CO. 282
BECTON DICKINSON & CO (FRANKLIN LAKES) 252
BECTON DICKINSON 81
BECTON, DICKINSON AND COMPANY (BD) 67
Becton Dickinson & CO (Franklin Lakes) 39

Event Locations

1,329 (67.6%)
I 624 (31.8%)
HOSPITAL 8 (0.4%)
OTHER 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare BECTON, DICKINSON & CO. (BROKEN BOW) vs BECTON, DICKINSON & CO. →

Nationwide devices with a comparable report-volume footprint

Tubes, Vacuum Sample, With Anticoagulant carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,965 here).

Radioimmunoassay, Total Triiodothyronine 1,979 Monitor, Physiological, Patient 1,983 Tourniquet, Pneumatic 1,989 Trocar 1,994

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Tubes, Vacuum Sample, With Anticoagulant 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 Tubes, Vacuum Sample, With Anticoagulant; 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.