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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, blood culturing
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
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 147 147
2020 37 37
2021 1184 1184
2022 643 643
2023 1232 1232
2024 102 102

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1763 1763
Incorrect, Inadequate or Imprecise Result or Readings 878 878
Contamination 230 230
False Negative Result 184 184
Device Markings/Labelling Problem 98 98
Leak/Splash 68 68
Contamination of Device Ingredient or Reagent 48 48
Microbial Contamination of Device 23 23
Fluid/Blood Leak 22 22
Unintended Movement 18 18
Missing Information 18 18
Break 16 16
Contamination /Decontamination Problem 12 12
Device Contamination with Chemical or Other Material 10 10
Crack 6 6
Data Problem 4 4
Patient Data Problem 3 3
Missing Test Results 3 3
Inaccurate Information 3 3
Cross Reactivity 3 3
Communication or Transmission Problem 3 3
Failure to Obtain Sample 3 3
Device Ingredient or Reagent Problem 3 3
Device-Device Incompatibility 2 2
Fire 2 2
Labelling, Instructions for Use or Training Problem 2 2
Physical Resistance/Sticking 2 2
Human-Device Interface Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 1 1
Positioning Problem 1 1
Misassembly by Users 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Unintended Electrical Shock 1 1
Audible Prompt/Feedback Problem 1 1
Excessive Heating 1 1
Misassembled During Installation 1 1
Fracture 1 1
Mechanical Problem 1 1
Failure to Power Up 1 1
Unable to Obtain Readings 1 1
Alarm Not Visible 1 1
Deflation Problem 1 1
Material Discolored 1 1
Difficult to Open or Close 1 1
Patient-Device Incompatibility 1 1
Device Contamination with Body Fluid 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Retraction Problem 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3086 3086
No Consequences Or Impact To Patient 134 134
No Known Impact Or Consequence To Patient 132 132
Insufficient Information 34 34
Misdiagnosis 19 19
No Patient Involvement 16 16
Bacterial Infection 10 10
No Information 5 5
Sepsis 5 5
Death 3 3
Headache 2 2
Pain 1 1
Pleural Effusion 1 1
Local Reaction 1 1
Fever 1 1
Fungus 1 1
Exposure to Body Fluids 1 1
Injury 1 1
Fungal Infection 1 1
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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