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2026 data FDA MAUDE openFDA FDA Class II

Set, Blood Transfusion

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 §880.5440 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Set, Blood Transfusion LIGHT-BOOK · MAUDE

#518 of 1000 · 1,836 reports · 1994–2026

  • BOOK 1,836 reports
  • RANK #518 of 1000
  • DEATH 9 death-typed
  • INJ 40 injury-typed
  • MALF 1,747 malfunction
  • SPAN 1994–2026
  • PEAK 2013: 175
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Nephrostomy, General & Plastic Surgery (1 report gap)

Set, Blood Transfusion sits #518 of 1000 among tracked device types with 1,836 MAUDE reports spanning 1994–2026. 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

Set, Blood Transfusion carries 95.2% MALFUNCTION-coded reports, 30.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 2.2% corpus 30.3% · below corpus mean (-28.1 pp)
  • MALF 95.2% corpus 64.8% · above corpus mean (+30.3 pp)

Lead product-problem code Fluid/Blood Leak is 35% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 40% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Set, Blood Transfusion in the event-volume neighbourhood

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

reports

What this shows Set, Blood Transfusion carries 1,836 MAUDE reports, ranked #518 of 1000.

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

Event Types

Malfunction 1,747 (95.2%)
Injury 40 (2.2%)
Other 27 (1.5%)
13 (0.7%)
Death 9 (0.5%)

Patient Outcomes

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

1,691 (91.9%)
Other 101 (5.5%)
Required Intervention 23 (1.2%)
Death 9 (0.5%)
R 4 (0.2%)
Disability 4 (0.2%)
Life Threatening 4 (0.2%)
Hospitalization 3 (0.2%)
H 1 (0.1%)
L 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 617
Disconnection 185
Leak/Splash 154
Material Separation 96
Break 73
No Flow 72
Crack 67
Detachment of Device or Device Component 57
Detachment Of Device Component 54
Device Contamination with Chemical or Other Material 50
Device Operates Differently Than Expected 48
Hole In Material 44
Air Leak 35
Filling Problem 35
Failure to Prime 34
Replace 34
Component Missing 32
Material Puncture/Hole 28
Backflow 25
Improper Flow or Infusion 25

Yearly Trend

94
1994: 8
95
1995: 7
96
1996: 11
97
1997: 22
98
1998: 19
99
1999: 22
00
2000: 5
01
2001: 10
02
2002: 10
03
2003: 25
04
2004: 18
05
2005: 31
06
2006: 25
07
2007: 12
08
2008: 12
09
2009: 17
10
2010: 71
11
2011: 123
12
2012: 141
13
2013: 175
14
2014: 108
15
2015: 171
16
2016: 78
17
2017: 82
18
2018: 66
19
2019: 85
20
2020: 90
21
2021: 60
22
2022: 55
23
2023: 67
24
2024: 89
25
2025: 70
26
2026: 51

Reports in 2025 (70) held close to the prior two-year average of 78.

Related Entities for Set, Blood Transfusion

Top Manufacturers

BAXTER HEALTHCARE CORPORATION 487
BAXTER HEALTHCARE - MALTA 322
BAXTER HEALTHCARE 121
BAXTER HEALTHCARE - AIBONITO 118
BAXTER HEALTHCARE - SINGAPORE 111
BAXTER HEALTHCARE CORP. 55

Event Locations

1,113 (60.6%)
I 482 (26.3%)
HOSPITAL 204 (11.1%)
OUTPATIENT TREATMENT FACILITY 11 (0.6%)
NO INFORMATION 7 (0.4%)
INVALID DATA 5 (0.3%)
NOT APPLICABLE 4 (0.2%)
UNKNOWN 4 (0.2%)
AMBULATORY SURGICAL FACILITY 3 (0.2%)
CRITICAL CARE UNIT 1 (0.1%)
HOME 1 (0.1%)
OTHER 1 (0.1%)

Compare BAXTER HEALTHCARE CORPORATION vs BAXTER HEALTHCARE - MALTA →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Set, Blood Transfusion: 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 (1,836 here).

Catheter 1,835 Pump 1,832 Marker, Radiographic, Implantable 1,851 Generator, Lesion, Radiofrequency 1,812

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Set, Blood Transfusion 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 Set, Blood Transfusion; 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.