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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, hemodialysis, implanted, coated
Regulation Description Blood access device and accessories.
Definition Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Product CodeNYU
Regulation Number 876.5540
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 16 20
2023 4 4
2024 15 15
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 14 14
Break 13 17
Insufficient Flow or Under Infusion 3 3
Defective Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Puncture/Hole 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Unraveled Material 2 2
Material Fragmentation 1 1
Leak/Splash 1 1
Device Difficult to Setup or Prepare 1 1
Pumping Problem 1 1
Insufficient Information 1 1
Failure to Advance 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 32
Insufficient Information 12 16
Unintended Radiation Exposure 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Dyspnea 2 2
Air Embolism 1 1
Unspecified Infection 1 1
Nausea 1 1
Dizziness 1 1
Malaise 1 1
Rash 1 1
Chest Pain 1 1
Numbness 1 1
Pain 1 1
Endocarditis 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1
Sore Throat 1 1
Loss of consciousness 1 1

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