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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
Product CodeKST
Regulation Number 864.9125
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 2 2
2022 1 1
2023 8 8
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4 4
Break 3 3
Crack 2 2
Defective Device 2 2
Gas/Air Leak 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Patient Device Interaction Problem 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Product Quality Problem 1 1

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

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