BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.

FDA MAUDE device safety record · 1999–2026

What the Data Shows About BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. is associated with 10,998 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1999 through 2026. Of the total, 4 are coded as death reports and 514 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 BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 10,477 reports (95.3% of total). Patient-outcome categorizations are reported across 10 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 24 years of MAUDE data, with the peak single-year volume reaching 2,108 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.

10,998
Total Reports
4
Death Reports
514
Injury Reports
20
Device Types

Event Types

Malfunction 10,477 (95.3%)
Injury 514 (4.7%)
Death 4 (0.0%)
Other 2 (0.0%)
1 (0.0%)

Patient Outcomes

7,062 (64.3%)
Other 3,557 (32.4%)
Required Intervention 320 (2.9%)
Life Threatening 16 (0.1%)
R 12 (0.1%)
Hospitalization 8 (0.1%)
O 7 (0.1%)
Death 4 (0.0%)
Disability 2 (0.0%)
L 1 (0.0%)

Yearly Trend

99
1999: 1
00
2000: 1
01
2001: 1
02
2002: 1
05
2005: 2
06
2006: 1
07
2007: 1
09
2009: 3
10
2010: 1
12
2012: 2
13
2013: 2
14
2014: 3
15
2015: 20
16
2016: 71
17
2017: 487
18
2018: 990
19
2019: 1,359
20
2020: 913
21
2021: 748
22
2022: 938
23
2023: 1,551
24
2024: 1,545
25
2025: 2,108
26
2026: 249

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.