BD MEDICAL - DIABETES CARE

FDA MAUDE device safety record · 2005–2025

What the Data Shows About BD MEDICAL - DIABETES CARE

BD MEDICAL - DIABETES CARE is associated with 8,115 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2005 through 2025. Of the total, 1 is coded as a death report and 290 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 13 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for BD MEDICAL - DIABETES CARE should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Malfunction at 7,823 reports (96.4% of total). Patient-outcome categorizations are reported across 9 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 15 years of MAUDE data, with the peak single-year volume reaching 1,831 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.

8,115
Total Reports
1
Death Reports
290
Injury Reports
13
Device Types

Event Types

Malfunction 7,823 (96.4%)
Injury 290 (3.6%)
1 (0.0%)
Death 1 (0.0%)

Patient Outcomes

Other 4,253 (52.5%)
3,680 (45.4%)
Required Intervention 145 (1.8%)
Disability 9 (0.1%)
Hospitalization 7 (0.1%)
R 6 (0.1%)
O 2 (0.0%)
Death 1 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

05
2005: 1
07
2007: 1
10
2010: 1
12
2012: 2
15
2015: 10
16
2016: 61
17
2017: 392
18
2018: 976
19
2019: 1,445
20
2020: 1,831
21
2021: 1,364
22
2022: 968
23
2023: 877
24
2024: 178
25
2025: 8

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.