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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, blood collection, vacuum-assisted, manual
Regulation Description Vacuum-assisted blood collection system.
Product CodeKST
Regulation Number 864.9125
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2022 1 1
2023 8 8
2024 5 5
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 3 3
Leak/Splash 2 2
Crack 2 2
Defective Device 2 2
Break 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Gas/Air Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Loose or Intermittent Connection 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Exposure to Body Fluids 4 4
Insufficient Information 3 3
Inflammation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1
Pain 1 1
Blurred Vision 1 1
Hemorrhage/Bleeding 1 1

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