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Culture Media, Non-Propagating Transport

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FDA MAUDE adverse event data · 1996–2026

What the Data Shows About Culture Media, Non-Propagating Transport

The FDA MAUDE database aggregates 576 adverse-event reports for Culture Media, Non-Propagating Transport spanning the period from 1996 through 2026. Of these, 1 is classified as a death report, 78 as injury reports, and 489 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 9 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 Leak/Splash topping the list at 91 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 22 years of MAUDE data, with the peak single-year volume reaching 131 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 6 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.

576
Total Reports
1
Death Reports
78
Injury Reports
489
Malfunctions

Event Types

Malfunction 489 (84.9%)
Injury 78 (13.5%)
Other 7 (1.2%)
1 (0.2%)
Death 1 (0.2%)

Patient Outcomes

Other 322 (55.5%)
226 (39.0%)
Required Intervention 24 (4.1%)
O 2 (0.3%)
R 2 (0.3%)
H 1 (0.2%)
L 1 (0.2%)
S 1 (0.2%)
Death 1 (0.2%)

Top Product Problems

Leak/Splash 91
Incorrect, Inadequate or Imprecise Result or Readings 65
Material Protrusion/Extrusion 40
Short Fill 32
Product Quality Problem 31
Break 28
Fluid/Blood Leak 24
Volume Accuracy Problem 24
Delivered as Unsterile Product 22
Incorrect Or Inadequate Test Results 19
Device Contamination with Chemical or Other Material 18
Device Markings/Labelling Problem 18
Component Missing 14
Detachment Of Device Component 12
Contamination /Decontamination Problem 11
Separation Problem 10
Adverse Event Without Identified Device or Use Problem 8
Device Ingredient or Reagent Problem 7
Improper or Incorrect Procedure or Method 7
Unsealed Device Packaging 7

Yearly Trend

96
1996: 2
97
1997: 3
00
2000: 1
02
2002: 16
04
2004: 3
09
2009: 1
11
2011: 1
12
2012: 9
13
2013: 1
14
2014: 2
15
2015: 1
16
2016: 6
17
2017: 57
18
2018: 131
19
2019: 81
20
2020: 47
21
2021: 42
22
2022: 36
23
2023: 48
24
2024: 21
25
2025: 65
26
2026: 2

Related Entities for Culture Media, Non-Propagating Transport

Event Locations

I 341 (59.2%)
192 (33.3%)
HOSPITAL 21 (3.6%)
OUTPATIENT DIAGNOSTIC FACILITY 14 (2.4%)
NO INFORMATION 6 (1.0%)
UNKNOWN 2 (0.3%)

Compare BECTON, DICKINSON & CO. (BROKEN BOW) vs BECTON, DICKINSON & CO. →

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.