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Culture Media, Non-Selective And Non-Differential

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FDA MAUDE adverse event data · 2008–2026

What the Data Shows About Culture Media, Non-Selective And Non-Differential

The FDA MAUDE database aggregates 866 adverse-event reports for Culture Media, Non-Selective And Non-Differential spanning the period from 2008 through 2026. Of these, 0 are classified as death reports, 21 as injury reports, and 842 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 3 distinct event types and 4 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 Incorrect, Inadequate or Imprecise Result or Readings topping the list at 408 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 16 years of MAUDE data, with the peak single-year volume reaching 228 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 4 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.

866
Total Reports
0
Death Reports
21
Injury Reports
842
Malfunctions

Event Types

Malfunction 842 (97.2%)
Injury 21 (2.4%)
Other 3 (0.3%)

Patient Outcomes

823 (95.0%)
Other 38 (4.4%)
Required Intervention 4 (0.5%)
Hospitalization 1 (0.1%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 408
Contamination 237
Device Markings/Labelling Problem 76
Contamination of Device Ingredient or Reagent 57
Microbial Contamination of Device 18
Device Contamination with Chemical or Other Material 16
Missing Information 6
Contamination /Decontamination Problem 3
False Negative Result 3
Fluid/Blood Leak 3
Break 2
False Positive Result 2
Material Opacification 2
Output Problem 2
Product Quality Problem 2
Adverse Event Without Identified Device or Use Problem 1
Component Missing 1
Connection Problem 1
Device Contaminated During Manufacture or Shipping 1
Improper or Incorrect Procedure or Method 1

Yearly Trend

08
2008: 4
10
2010: 3
11
2011: 1
12
2012: 7
13
2013: 1
14
2014: 1
16
2016: 1
17
2017: 3
19
2019: 25
20
2020: 1
21
2021: 177
22
2022: 198
23
2023: 182
24
2024: 32
25
2025: 228
26
2026: 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.