CAREFUSION 303, INC.

FDA MAUDE device safety record · 2010–2026

What the Data Shows About CAREFUSION 303, INC.

CAREFUSION 303, INC. is associated with 64,508 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2010 through 2026. Of the total, 25 are coded as death reports and 121 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for CAREFUSION 303, INC. should be reviewed at the device-family level rather than company-wide. Across those devices, 6 distinct event types appear in the record, led by Malfunction at 64,316 reports (99.7% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 17 years of MAUDE data, with the peak single-year volume reaching 53,359 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

64,508
Total Reports
25
Death Reports
121
Injury Reports
20
Device Types

Event Types

Malfunction 64,316 (99.7%)
Injury 121 (0.2%)
37 (0.1%)
Death 25 (0.0%)
Other 8 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

62,709 (99.5%)
Other 125 (0.2%)
Required Intervention 52 (0.1%)
Life Threatening 32 (0.1%)
Death 26 (0.0%)
R 23 (0.0%)
Hospitalization 13 (0.0%)
O 10 (0.0%)
L 9 (0.0%)
H 5 (0.0%)
S 2 (0.0%)
Congenital Anomaly 2 (0.0%)
C 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

10
2010: 5
11
2011: 5
12
2012: 30
13
2013: 44
14
2014: 56
15
2015: 110
16
2016: 165
17
2017: 193
18
2018: 198
19
2019: 216
20
2020: 215
21
2021: 165
22
2022: 316
23
2023: 508
24
2024: 1,671
25
2025: 53,359
26
2026: 7,252

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.