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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
2020 4 4
2021 1 1
2022 16 16
2023 4 4
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 14 14
Break 11 11
Material Puncture/Hole 4 4
Insufficient Flow or Under Infusion 3 3
Product Quality Problem 2 2
Defective Component 2 2
Detachment of Device or Device Component 1 1
Material Fragmentation 1 1
Unraveled Material 1 1
Leak/Splash 1 1
Insufficient Information 1 1
Pumping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Integrity Problem 1 1
Device Difficult to Setup or Prepare 1 1
Difficult to Remove 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
Insufficient Information 12 12
Unintended Radiation Exposure 5 5
No Consequences Or Impact To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Infection 1 1
Bacterial Infection 1 1
Rash 1 1
Endocarditis 1 1
Chest Pain 1 1
Hemorrhage/Bleeding 1 1
Numbness 1 1
Dyspnea 1 1
Pain 1 1
Air Embolism 1 1

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