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Stand, Infusion

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Stand, Infusion

The FDA MAUDE database aggregates 430 adverse-event reports for Stand, Infusion spanning the period from 1992 through 2026. Of these, 5 are classified as death reports, 42 as injury reports, and 369 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 11 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Detachment of Device or Device Component topping the list at 118 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 30 years of MAUDE data, with the peak single-year volume reaching 173 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 9 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

430
Total Reports
5
Death Reports
42
Injury Reports
369
Malfunctions

Event Types

Malfunction 369 (85.8%)
Injury 42 (9.8%)
7 (1.6%)
Other 7 (1.6%)
Death 5 (1.2%)

Patient Outcomes

Other 203 (45.9%)
185 (41.9%)
Required Intervention 31 (7.0%)
R 6 (1.4%)
Death 5 (1.1%)
Hospitalization 4 (0.9%)
O 2 (0.5%)
S 2 (0.5%)
Life Threatening 2 (0.5%)
H 1 (0.2%)
Invalid Data 1 (0.2%)

Top Product Problems

Detachment of Device or Device Component 118
Misconnection 72
Loss of or Failure to Bond 38
Adverse Event Without Identified Device or Use Problem 19
Difficult to Open or Close 16
Disconnection 16
Material Twisted/Bent 16
Break 12
Defective Component 9
Loose or Intermittent Connection 9
Contamination /Decontamination Problem 8
Malposition of Device 8
Crack 5
Material Separation 5
Mechanical Problem 5
Difficult to Remove 4
Fluid/Blood Leak 4
Product Quality Problem 4
Component Missing 3
Defective Device 3

Yearly Trend

92
1992: 3
94
1994: 2
96
1996: 5
97
1997: 4
98
1998: 2
02
2002: 3
03
2003: 1
04
2004: 5
05
2005: 2
06
2006: 3
07
2007: 4
08
2008: 3
09
2009: 2
10
2010: 3
11
2011: 10
12
2012: 5
13
2013: 7
14
2014: 2
15
2015: 3
16
2016: 2
17
2017: 8
18
2018: 17
19
2019: 23
20
2020: 112
21
2021: 173
22
2022: 12
23
2023: 3
24
2024: 6
25
2025: 3
26
2026: 2

Related Entities for Stand, Infusion

Event Locations

I 226 (52.6%)
HOSPITAL 144 (33.5%)
47 (10.9%)
HOME 4 (0.9%)
NO INFORMATION 3 (0.7%)
INVALID DATA 2 (0.5%)
OTHER 2 (0.5%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
UNKNOWN 1 (0.2%)

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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 device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.