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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device system, blood culturing
Regulation Description Microbial growth monitor.
Product CodeMDB
Regulation Number 866.2560
Device Class 1


Premarket Reviews
ManufacturerDecision
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 37 37
2021 1184 1184
2022 643 643
2023 1232 1232
2024 400 400
2025 112 112

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1793 1793
Incorrect, Inadequate or Imprecise Result or Readings 978 978
False Negative Result 225 225
Contamination 198 198
Device Markings/Labelling Problem 121 121
Leak/Splash 86 86
Cross Reactivity 83 83
Contamination of Device Ingredient or Reagent 48 48
Microbial Contamination of Device 26 26
Unintended Movement 20 20
Missing Information 19 19
Fluid/Blood Leak 17 17
Break 15 15
Device Contamination with Chemical or Other Material 13 13
Contamination /Decontamination Problem 12 12
Fire 5 5
Data Problem 4 4
Device Ingredient or Reagent Problem 3 3
Communication or Transmission Problem 3 3
Inaccurate Information 3 3
Crack 3 3
Failure to Obtain Sample 3 3
Missing Test Results 3 3
Patient Data Problem 3 3
Product Quality Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Patient-Device Incompatibility 2 2
Device-Device Incompatibility 2 2
Material Integrity Problem 1 1
Alarm Not Visible 1 1
Unable to Obtain Readings 1 1
Failure to Power Up 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Audible Prompt/Feedback Problem 1 1
Misassembly by Users 1 1
Defective Component 1 1
Unintended Electrical Shock 1 1
Device Damaged Prior to Use 1 1
Physical Resistance/Sticking 1 1
Output Problem 1 1
Excessive Heating 1 1
Device Contamination with Body Fluid 1 1
Difficult to Open or Close 1 1
Mechanical Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3491 3491
No Consequences Or Impact To Patient 123 123
Insufficient Information 36 36
No Known Impact Or Consequence To Patient 19 19
No Patient Involvement 10 10
Bacterial Infection 10 10
Misdiagnosis 6 6
Sepsis 5 5
No Information 5 5
Death 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Drug Resistant Bacterial Infection 1 1
Fungus 1 1
Fungal Infection 1 1
Crushing Injury 1 1
Local Reaction 1 1
Blister 1 1
Fever 1 1
Pleural Effusion 1 1
Pain 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Dec-03-2024
2 Becton Dickinson & Co. II Oct-12-2023
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