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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microfilter, blood transfusion
Regulation Description Intravascular administration set.
Product CodeCAK
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2020 180 180
2021 18 18
2022 110 110
2023 69 69
2024 19 19
2025 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 355 355
Coagulation in Device or Device Ingredient 73 73
Filtration Problem 70 70
Insufficient Information 65 65
Restricted Flow rate 45 45
Contamination of Device Ingredient or Reagent 41 41
High Readings 39 39
High Test Results 38 38
Defective Component 17 17
Therapeutic or Diagnostic Output Failure 13 13
Inadequate Filtration Process 9 9
No Apparent Adverse Event 5 5
Device Ingredient or Reagent Problem 4 4
Obstruction of Flow 4 4
Use of Device Problem 3 3
Misassembled 3 3
Misassembly by Users 3 3
Improper Chemical Reaction 2 2
Pressure Problem 1 1
Device Damaged Prior to Use 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Contamination /Decontamination Problem 1 1
Device Difficult to Setup or Prepare 1 1
Partial Blockage 1 1
Product Quality Problem 1 1
Fungus in Device Environment 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 252 252
No Patient Involvement 160 160
No Consequences Or Impact To Patient 61 61
No Known Impact Or Consequence To Patient 25 25
Hemolysis 5 5
Insufficient Information 2 2
Perforation of Esophagus 1 1
Alteration in Body Temperature 1 1
Pain 1 1

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