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TPLC
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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 Code
NYU
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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