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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 244 244

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1772 1772
Incorrect, Inadequate or Imprecise Result or Readings 929 929
Contamination 232 232
False Negative Result 209 209
Device Markings/Labelling Problem 106 106
Leak/Splash 75 75
Contamination of Device Ingredient or Reagent 48 48
Cross Reactivity 33 33
Microbial Contamination of Device 26 26
Fluid/Blood Leak 22 22
Missing Information 19 19
Unintended Movement 18 18
Break 16 16
Device Contamination with Chemical or Other Material 13 13
Contamination /Decontamination Problem 12 12
Crack 6 6
Data Problem 4 4
Inaccurate Information 3 3
Device Ingredient or Reagent Problem 3 3
Communication or Transmission Problem 3 3
Missing Test Results 3 3
Failure to Obtain Sample 3 3
Patient Data Problem 3 3
Human-Device Interface 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
Fire 2 2
Physical Resistance/Sticking 2 2
Device-Device Incompatibility 2 2
Product Quality Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Integrity Problem 1 1
Expiration Date Error 1 1
Positioning Problem 1 1
Defective Component 1 1
Smoking 1 1
Deflation Problem 1 1
Device Damaged Prior to Use 1 1
Unintended Electrical Shock 1 1
Mechanical Problem 1 1
Output Problem 1 1
Alarm Not Visible 1 1
Misassembled During Installation 1 1
Unable to Obtain Readings 1 1
Failure to Power Up 1 1
Material Discolored 1 1
Audible Prompt/Feedback Problem 1 1
Device Contamination with Body Fluid 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3226 3226
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
Sepsis 5 5
No Information 5 5
Death 3 3
Headache 2 2
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Fungus 1 1
Fungal Infection 1 1
Crushing Injury 1 1
Local Reaction 1 1
Blister 1 1
Fever 1 1
Injury 1 1
Exposure to Body Fluids 1 1
Pleural Effusion 1 1
Pain 1 1

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