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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §864.9100 (Hematology panel).

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FDA MAUDE casebook

openFDA event book Container LIGHT-BOOK · MAUDE

#819 of 1000 · 615 reports · 1992–2026

  • BOOK 615 reports
  • RANK #819 of 1000
  • DEATH 8 death-typed
  • INJ 27 injury-typed
  • MALF 526 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 82
  • PHOTO Rongeur

Nearest event-volume peer: Rongeur (0 report gap)

Container, Empty, For Collection & Processing Of Blood & Blood Components sits #819 of 1000 among tracked device types with 615 MAUDE reports spanning 1992–2026. 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 →

Injury-coded reports sit below the device-type norm

Container carries 4.4% INJURY-coded reports, 25.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 4.4% corpus 30.3% · below corpus mean (-25.9 pp)
  • MALF 85.5% corpus 64.8% · above corpus mean (+20.7 pp)

Lead product-problem code Leak/Splash 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 615 MAUDE reports, ranked #819 of 1000.

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

Event Types

Malfunction 526 (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 (69.7%)
Other 145 (23.0%)
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

Leak/Splash 102
Device Operates Differently Than Expected 63
Break 62
Fluid/Blood Leak 58
Crack 47
Adverse Event Without Identified Device or Use Problem 37
Fracture 36
Insufficient Device Problem Information 35
Appropriate Device Problem Term/Code Not Available 24
Device Contamination with Chemical or Other Material 16
Burst Container or Vessel 12
Filter leak(s) 12
Material Separation 11
Detachment Of Device Component 10
Replace 9
Detachment of Device or Device Component 8
High Test Results 8
Loose or Intermittent Connection 8
Tears, rips, holes in device, device material 8
Material Integrity Problem 7

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
26
2026: 1

Reports fell to 11 in 2025, down from an average of 23 in the two years before.

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

321 (52.2%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Container: 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 (615 here).

Rongeur 615 Integrated Continuous Glucose Monitoring Sy… 620 Monitor, Apnea, Facility Use 620 Gram-Positive Bacteria And Their Resistance… 621

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.