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2026 data FDA MAUDE openFDA FDA Class II

Blood/Plasma Collection Device For Dna Testing

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 Blood/Plasma Collection Device For Dna Test… LIGHT-BOOK · MAUDE

#840 of 1000 · 581 reports · 2018–2026

  • BOOK 581 reports
  • RANK #840 of 1000
  • DEATH 0 death-typed
  • INJ 0 injury-typed
  • MALF 581 malfunction
  • SPAN 2018–2026
  • PEAK 2025: 264
  • PHOTO Culture Media

Nearest event-volume peer: Culture Media, Non-Propagating Transport (0 report gap)

Blood/Plasma Collection Device For Dna Testing sits #840 of 1000 among tracked device types with 581 MAUDE reports spanning 2018–2026. 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

Blood/Plasma Collection Device For Dna Test… carries 100.0% MALFUNCTION-coded reports, 35.2pp 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 0.0% corpus 30.3% · below corpus mean (-30.3 pp)
  • MALF 100.0% corpus 64.8% · above corpus mean (+35.2 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 42% of coded problems · Lead manufacturer BECTON, DICKINSON & CO. (BROKEN BOW) accounts for 85% of manufacturer-tagged reports · Top event location is 91% of location-tagged rows .

Blood/Plasma Collection Device For Dna Test… in the event-volume neighbourhood

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

reports

What this shows Blood/Plasma Collection Device For Dna Testing carries 581 MAUDE reports, ranked #840 of 1000.

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

Event Types

Malfunction 581 (100.0%)

Patient Outcomes

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

540 (92.9%)
Other 41 (7.1%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 250
Device Ingredient or Reagent Problem 148
Device Contamination with Chemical or Other Material 74
Short Fill 35
Device Markings/Labelling Problem 21
Leak/Splash 13
Incorrect Or Inadequate Test Results 9
Volume Accuracy Problem 9
Material Deformation 6
Material Discolored 5
Coagulation in Device or Device Ingredient 4
Fluid/Blood Leak 4
Particulates 4
Fracture 3
Improper Chemical Reaction 3
Break 2
Component Missing 2
Crack 2
Improper or Incorrect Procedure or Method 2
Inaccurate Information 2

Yearly Trend

18
2018: 27
19
2019: 12
20
2020: 3
21
2021: 14
22
2022: 16
23
2023: 63
24
2024: 168
25
2025: 264
26
2026: 14

Reports rose to 264 in 2025, up from an average of 116 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Blood/Plasma Collection Device For Dna Testing

Top Manufacturers

BECTON, DICKINSON & CO. (BROKEN BOW) 490
BECTON, DICKINSON AND COMPANY (BD) 53
BECTON DICKINSON & CO (FRANKLIN LAKES) 16
BECTON DICKINSON 12
BD (SUZHOU) 3
BECTON, DICKINSON & CO. 3
Becton Dickinson & CO (Franklin Lakes) 1

Event Locations

529 (91.0%)
I 52 (9.0%)

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

Nationwide devices with a comparable report-volume footprint

Blood/Plasma Collection Device For Dna Test… 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 (581 here).

Culture Media, Non-Propagating Transport 581 Applier, Staple, Surgical, 580 Calibrator, Multi-Analyte Mixture 582 Counter, Sponge, Surgical 579

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 Blood/Plasma Collection Device For Dna Test… 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 Blood/Plasma Collection Device For Dna Test…; 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.