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2025 data FDA MAUDE openFDA

Container, Empty, For Collection & Processing Of Blood & Blood Components

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.

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FDA MAUDE casebook

openFDA event book Container LIGHT-BOOK · MAUDE

#804 of 1000 · 614 reports · 1992–2025

  • BOOK 614 reports
  • RANK #804 of 1000
  • DEATH 8 death-typed
  • INJ 27 injury-typed
  • MALF 525 malfunction
  • SPAN 1992–2025
  • PEAK 2009: 82
  • PHOTO Nebulizer

Nearest event-volume peer: Nebulizer, Medicinal, Non-Ventilatory (Atomizer) (1 report gap)

Container, Empty, For Collection & Processing Of Blood & Blood Components sits #804 of 1000 among tracked device types with 614 MAUDE reports spanning 1992–2025. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 4.4% corpus 30.4% · below corpus mean (-26.0 pp)
  • MALF 85.5% corpus 64.5% · above corpus mean (+21.0 pp)

Lead product-problem code Fracture is 18% of coded problems · Lead manufacturer TERUMO BCT accounts for 32% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Container in the event-volume neighbourhood

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

reports

What this shows Container, Empty, For Collection & Processing Of Blood & Blood Components carries 614 MAUDE reports, ranked #804 of 1000.

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

Event Types

Malfunction 525 (85.5%)
48 (7.8%)
Injury 27 (4.4%)
Death 8 (1.3%)
Other 6 (1.0%)

Patient Outcomes

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

439 (69.8%)
Other 144 (22.9%)
Required Intervention 14 (2.2%)
Death 9 (1.4%)
H 5 (0.8%)
O 4 (0.6%)
R 4 (0.6%)
Hospitalization 3 (0.5%)
L 2 (0.3%)
Invalid Data 2 (0.3%)
Disability 1 (0.2%)
Life Threatening 1 (0.2%)
Not Applicable 1 (0.2%)

Top Product Problems

Fracture 34
Adverse Event Without Identified Device or Use Problem 32
Insufficient Information 30
Appropriate Term/Code Not Available 21
Crack 14
Fluid/Blood Leak 8
Detachment of Device or Device Component 7
Burst Container or Vessel 6
Break 5
Leak/Splash 5
Material Puncture/Hole 5
Material Integrity Problem 4
Defective Component 3
Loose or Intermittent Connection 3
Particulates 2
Component Missing 1
Device Contamination with Chemical or Other Material 1
Device Markings/Labelling Problem 1
Filtration Problem 1
Free or Unrestricted Flow 1

Yearly Trend

92
1992: 6
93
1993: 4
94
1994: 11
95
1995: 3
96
1996: 20
97
1997: 29
98
1998: 4
99
1999: 2
00
2000: 1
02
2002: 3
03
2003: 3
04
2004: 13
05
2005: 9
06
2006: 24
07
2007: 46
08
2008: 47
09
2009: 82
10
2010: 39
11
2011: 11
12
2012: 41
13
2013: 71
14
2014: 11
15
2015: 8
16
2016: 5
17
2017: 4
18
2018: 3
19
2019: 9
20
2020: 21
21
2021: 17
22
2022: 11
23
2023: 20
24
2024: 25
25
2025: 11

Related Entities for Container, Empty, For Collection & Processing Of Blood & Blood Components

Top Manufacturers

TERUMO BCT 69
BAXTER HEALTHCARE - MOUNTAIN HOME 63
BAXTER HEALTHCARE 38
BAXTER HEALTHCARE CORP. 31
BAXTER HEALTHCARE CORPORATION 14

Event Locations

320 (52.1%)
OTHER 118 (19.2%)
HOSPITAL 51 (8.3%)
INVALID DATA 49 (8.0%)
I 45 (7.3%)
NO INFORMATION 19 (3.1%)
BLOOD BANK 4 (0.7%)
OUTPATIENT TREATMENT FACILITY 4 (0.7%)
LABORATORY 1 (0.2%)
NOT APPLICABLE 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare TERUMO BCT vs BAXTER HEALTHCARE - MOUNTAIN HOME →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Container, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (614 here).

Nebulizer, Medicinal, Non-Ventilatory 615 Table 615 Gram-Positive Bacteria And Their Resistance… 612 System, Communication, Powered 616

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Agent 8 Bronchoscope Accessory 8 Catheter, Balloon, Transcervical 8 Catheter, Nephrostomy 8

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

Disclaimer: MAUDE figures for Container 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 Container; 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.