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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
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
2019 6 6
2020 4 4
2021 1 1
2022 16 16
2023 4 4
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 14 14
Break 12 12
Material Puncture/Hole 6 6
Leak/Splash 5 5
Insufficient Flow or Under Infusion 3 3
Product Quality Problem 2 2
Component Missing 2 2
Defective Component 2 2
Unraveled Material 1 1
Material Fragmentation 1 1
Detachment of Device or Device Component 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pumping Problem 1 1
Insufficient Information 1 1
Difficult to Remove 1 1
Material Frayed 1 1
Device Difficult to Setup or Prepare 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Insufficient Information 15 15
No Consequences Or Impact To Patient 9 9
Unintended Radiation Exposure 4 4
No Information 2 2
Unspecified Infection 1 1
Dyspnea 1 1
Rash 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1
Endocarditis 1 1
Numbness 1 1
Bacterial Infection 1 1
Air Embolism 1 1

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