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2026 data FDA MAUDE openFDA FDA Class II

Tubes, Vials, Systems, Serum Separators, Blood Collection

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 MID-BOOK · MAUDE

#73 of 1000 · 48,656 reports · 1993–2026

  • BOOK 48,656 reports
  • RANK #73 of 1000
  • DEATH 3 death-typed
  • INJ 1,289 injury-typed
  • MALF 47,068 malfunction
  • SPAN 1993–2026
  • PEAK 2018: 9,731
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (343 report gap)

Tubes, Vials, Systems, Serum Separators, Blood Collection sits #73 of 1000 among tracked device types with 48,656 MAUDE reports spanning 1993–2026. 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 carries 96.7% MALFUNCTION-coded reports, 31.9pp 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 2.6% corpus 30.3% · below corpus mean (-27.6 pp)
  • MALF 96.7% corpus 64.8% · above corpus mean (+31.9 pp)

Lead product-problem code Short Fill is 16% of coded problems · Lead manufacturer BECTON, DICKINSON AND COMPANY (BD) accounts for 35% of manufacturer-tagged reports · Top event location I is 51% of location-tagged rows .

Tubes in the event-volume neighbourhood

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

reports

What this shows Tubes, Vials, Systems, Serum Separators, Blood Collection carries 48,656 MAUDE reports, ranked #73 of 1000.

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

Event Types

Malfunction 47,068 (96.7%)
Injury 1,289 (2.6%)
Other 260 (0.5%)
35 (0.1%)
Death 3 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

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

26,315 (54.2%)
Other 21,454 (44.2%)
Required Intervention 614 (1.3%)
Hospitalization 37 (0.1%)
R 34 (0.1%)
O 24 (0.0%)
Death 15 (0.0%)
Life Threatening 11 (0.0%)
Disability 5 (0.0%)
L 3 (0.0%)
D 1 (0.0%)
H 1 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Short Fill 7,780
Incorrect, Inadequate or Imprecise Result or Readings 6,595
Leak/Splash 6,481
Device Contamination with Chemical or Other Material 5,336
Volume Accuracy Problem 2,865
Fluid/Blood Leak 2,551
Incorrect Or Inadequate Test Results 2,388
Device Ingredient or Reagent Problem 2,333
Device Markings/Labelling Problem 1,907
Overfill 1,699
Coagulation in Device or Device Ingredient 1,559
Material Deformation 1,542
Break 1,237
Product Quality Problem 933
Separation Problem 811
Difficult to Insert 689
Difficult or Delayed Activation 667
Component Missing 595
Crack 510
Improper Chemical Reaction 394

Yearly Trend

93
1993: 2
94
1994: 15
95
1995: 16
96
1996: 62
97
1997: 56
98
1998: 94
99
1999: 78
00
2000: 93
01
2001: 58
02
2002: 73
03
2003: 24
04
2004: 38
05
2005: 40
06
2006: 37
07
2007: 73
08
2008: 78
09
2009: 42
10
2010: 37
11
2011: 67
12
2012: 54
13
2013: 33
14
2014: 68
15
2015: 41
16
2016: 65
17
2017: 2,039
18
2018: 9,731
19
2019: 6,469
20
2020: 3,774
21
2021: 3,610
22
2022: 3,375
23
2023: 4,400
24
2024: 4,610
25
2025: 6,171
26
2026: 3,233

Reports in 2025 (6,171) held close to the prior two-year average of 4,505.

Related Entities for Tubes, Vials, Systems, Serum Separators, Blood Collection

Top Manufacturers

BECTON, DICKINSON AND COMPANY (BD) 15,326
BECTON, DICKINSON & CO., (BD) 9,436
BECTON, DICKINSON & CO. (BROKEN BOW) 7,859
BECTON, DICKINSON & CO. 4,292
BECTON DICKINSON 3,380
BECTON DICKINSON & CO (FRANKLIN LAKES) 2,689
SMITHS MEDICAL ASD, INC. 470
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 333

Event Locations

I 24,751 (50.9%)
22,832 (46.9%)
HOSPITAL 680 (1.4%)
OTHER 172 (0.4%)
NO INFORMATION 46 (0.1%)
UNKNOWN 44 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 38 (0.1%)
OUTPATIENT TREATMENT FACILITY 34 (0.1%)
INVALID DATA 27 (0.1%)
HOME 11 (0.0%)
NOT APPLICABLE 6 (0.0%)
CLINIC - WALK IN, OTHER 4 (0.0%)
NURSING HOME 4 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
DIALYSIS CENTER 2 (0.0%)
LABORATORY 2 (0.0%)
BLOOD BANK 1 (0.0%)

Compare BECTON, DICKINSON AND COMPANY (BD) vs BECTON, DICKINSON & CO., (BD) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tubes: 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 (48,656 here).

Catheter 48,999 Gas-Machine, Anesthesia 47,945 Sv70 Ventilator 47,855 Interventional Fluoroscopic X-Ray System 49,982

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Tubes 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; 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.