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2026 data FDA MAUDE openFDA FDA Class I

System, Blood Culturing

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §866.2560 (Microbiology panel).

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FDA MAUDE casebook

openFDA event book System, Blood Culturing LIGHT-BOOK · MAUDE

#281 of 1000 · 6,354 reports · 1996–2026

  • BOOK 6,354 reports
  • RANK #281 of 1000
  • DEATH 13 death-typed
  • INJ 154 injury-typed
  • MALF 6,180 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 1,983
  • PHOTO Device

Nearest event-volume peer: Device, Thermal Ablation, Endometrial (42 report gap)

System, Blood Culturing sits #281 of 1000 among tracked device types with 6,354 MAUDE reports spanning 1996–2026. 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

System, Blood Culturing carries 97.3% MALFUNCTION-coded reports, 32.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 2.4% corpus 30.3% · below corpus mean (-27.9 pp)
  • MALF 97.3% corpus 64.8% · above corpus mean (+32.4 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 39% of coded problems · Lead manufacturer BECTON DICKINSON & CO. (SPARKS) accounts for 56% of manufacturer-tagged reports · Top event location is 81% of location-tagged rows .

System, Blood Culturing in the event-volume neighbourhood

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

reports

What this shows System, Blood Culturing carries 6,354 MAUDE reports, ranked #281 of 1000.

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

Event Types

Malfunction 6,180 (97.3%)
Injury 154 (2.4%)
Death 13 (0.2%)
Other 6 (0.1%)
1 (0.0%)

Patient Outcomes

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

6,058 (96.1%)
Required Intervention 109 (1.7%)
Other 99 (1.6%)
Death 13 (0.2%)
Life Threatening 13 (0.2%)
Hospitalization 6 (0.1%)
R 2 (0.0%)
S 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 2,610
False Positive Result 2,453
False Negative Result 464
Contamination 458
Device Markings/Labelling Problem 141
Leak/Splash 119
Cross Reactivity 103
Contamination of Device Ingredient or Reagent 48
Microbial Contamination of Device 35
Break 31
Fluid/Blood Leak 29
Incorrect Or Inadequate Test Results 21
Unintended Movement 20
Missing Information 19
Device Displays Incorrect Message 16
Crack 15
Device Operates Differently Than Expected 15
Overheating of Device 15
Device Contamination with Chemical or Other Material 14
Contamination /Decontamination Problem 13

Yearly Trend

96
1996: 2
97
1997: 2
98
1998: 1
99
1999: 1
02
2002: 2
03
2003: 3
04
2004: 1
07
2007: 1
08
2008: 3
09
2009: 1
10
2010: 1
11
2011: 6
12
2012: 4
13
2013: 5
14
2014: 1
15
2015: 12
16
2016: 291
17
2017: 121
18
2018: 76
19
2019: 147
20
2020: 37
21
2021: 1,184
22
2022: 643
23
2023: 1,232
24
2024: 401
25
2025: 1,983
26
2026: 193

Reports rose to 1,983 in 2025, up from an average of 817 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for System, Blood Culturing

Top Manufacturers

BECTON DICKINSON & CO. (SPARKS) 1,512
BECTON, DICKINSON & CO. (SPARKS) 1,197

Event Locations

5,157 (81.2%)
I 1,177 (18.5%)
HOSPITAL 10 (0.2%)
NOT APPLICABLE 5 (0.1%)
INVALID DATA 2 (0.0%)
NO INFORMATION 2 (0.0%)
OTHER 1 (0.0%)

Compare BECTON DICKINSON & CO. (SPARKS) vs BECTON, DICKINSON & CO. (SPARKS) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Blood Culturing: 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 (6,354 here).

Device, Thermal Ablation, Endometrial 6,312 Catheter 6,232 System, Imaging, Pulsed Echo, Ultrasonic 6,516 Prosthesis, Intervertebral Disc 6,148

Similar death-typed counts

Nearest other device types by death-typed report count (13 here), distinct from the volume row.

Apparatus 13 Bariatric Bed 13 Chair, With Casters 13 Continuous Measurement Thermometer 13

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

Disclaimer: MAUDE figures for System, Blood Culturing 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 System, Blood Culturing; 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.