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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
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 76 76
2019 147 147
2020 37 37
2021 1184 1184
2022 643 643
2023 401 401

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 995 995
Incorrect, Inadequate or Imprecise Result or Readings 844 844
Contamination 243 243
False Negative Result 166 166
Device Markings/Labelling Problem 78 78
Leak/Splash 65 65
Contamination of Device Ingredient or Reagent 32 32
Microbial Contamination of Device 24 24
Fluid/Blood Leak 23 23
Unintended Movement 18 18
Break 17 17
Missing Information 14 14
Contamination /Decontamination Problem 13 13
Crack 7 7
Device Contamination with Chemical or Other Material 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Data Problem 4 4
Patient Data Problem 3 3
Missing Test Results 3 3
Communication or Transmission Problem 3 3
Failure to Obtain Sample 3 3
Date/Time-Related Software Problem 3 3
Incorrect Or Inadequate Test Results 2 2
Device Ingredient or Reagent Problem 2 2
Device Damaged Prior to Use 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
Material Integrity Problem 1 1
Output Problem 1 1
Positioning Problem 1 1
Difficult to Open or Close 1 1
Intermittent Loss of Power 1 1
Unintended Electrical Shock 1 1
Audible Prompt/Feedback Problem 1 1
Excessive Heating 1 1
Misassembled During Installation 1 1
Inaccurate Information 1 1
Misassembly by Users 1 1
Fracture 1 1
Mechanical Problem 1 1
Failure to Power Up 1 1
Unable to Obtain Readings 1 1
Deflation Problem 1 1
Material Discolored 1 1
Alarm Not Visible 1 1
Fire 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Retraction Problem 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2171 2171
No Known Impact Or Consequence To Patient 172 172
No Consequences Or Impact To Patient 135 135
Misdiagnosis 31 31
No Patient Involvement 30 30
Insufficient Information 17 17
Bacterial Infection 12 12
Death 6 6
No Information 5 5
Sepsis 5 5
Exposure to Body Fluids 3 3
Headache 2 2
Injury 2 2
Needle Stick/Puncture 2 2
Fungal Infection 1 1
Patient Problem/Medical Problem 1 1
Unspecified Infection 1 1
Pain 1 1
Pleural Effusion 1 1
Local Reaction 1 1
Fever 1 1
Fungus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Oct-24-2018
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