BARD ACCESS SYSTEMS

Manufacturer adverse-event records come from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

FDA MAUDE device safety record · 1992โ€“2024

What the Data Shows About BARD ACCESS SYSTEMS

BARD ACCESS SYSTEMS is associated with 18,708 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1992 through 2024. Of the total, 144 are coded as death reports and 3,568 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 BARD ACCESS SYSTEMS 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 14,844 reports (79.3% 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 33 years of MAUDE data, with the peak single-year volume reaching 3,949 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.

18,708
Total Reports
144
Death Reports
3,568
Injury Reports
20
Device Types

Event Types

Malfunction 14,844 (79.3%)
Injury 3,568 (19.1%)
Death 144 (0.8%)
95 (0.5%)
Other 57 (0.3%)

Patient Outcomes

13,212 (68.9%)
Required Intervention 4,288 (22.4%)
Other 612 (3.2%)
R 334 (1.7%)
Hospitalization 314 (1.6%)
Death 131 (0.7%)
Life Threatening 101 (0.5%)
Disability 50 (0.3%)
O 47 (0.2%)
L 43 (0.2%)
S 21 (0.1%)
Congenital Anomaly 4 (0.0%)
Invalid Data 4 (0.0%)
H 3 (0.0%)

Yearly Trend

92
1992: 3
93
1993: 15
94
1994: 52
95
1995: 45
96
1996: 218
97
1997: 749
98
1998: 429
99
1999: 369
00
2000: 612
01
2001: 267
02
2002: 124
03
2003: 142
04
2004: 73
05
2005: 67
06
2006: 56
07
2007: 82
08
2008: 75
09
2009: 43
10
2010: 35
11
2011: 53
12
2012: 24
13
2013: 28
14
2014: 279
15
2015: 478
16
2016: 746
17
2017: 2,381
18
2018: 3,841
19
2019: 3,949
20
2020: 3,421
21
2021: 46
22
2022: 3
23
2023: 2
24
2024: 1

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.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. This page draws directly on federal source data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.