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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lymphocyte separation medium
Regulation Description Lymphocyte separation medium.
Product CodeJCF
Regulation Number 864.8500
Device Class 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 10 10
2022 7 7
2023 4 4
2024 54 54
2025 116 116
2026 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Device Ingredient or Reagent Problem 71 71
Incorrect, Inadequate or Imprecise Result or Readings 70 70
Break 28 28
Short Fill 21 21
Fluid/Blood Leak 15 15
Device Contamination with Chemical or Other Material 13 13
Improper Chemical Reaction 7 7
Coagulation in Device or Device Ingredient 6 6
Material Deformation 4 4
Fracture 4 4
Volume Accuracy Problem 4 4
Clumping in Device or Device Ingredient 4 4
Leak/Splash 4 4
Component Missing 1 1
Device Markings/Labelling Problem 1 1
Inaccurate Information 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 223 223
No Consequences Or Impact To Patient 6 6
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 1 1
Exposure to Body Fluids 1 1

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