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TPLC
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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 Code
NYU
Regulation Number
876.5540
Device Class
2
Premarket Reviews
Manufacturer
Decision
COVIDIEN
SUBSTANTIALLY EQUIVALENT - KIT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
1
1
2016
3
3
2017
5
5
2018
5
5
2019
6
6
2020
4
4
2021
1
1
2022
16
16
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
15
15
Leak/Splash
8
8
Material Puncture/Hole
6
6
Product Quality Problem
4
4
Crack
4
4
Insufficient Flow or Under Infusion
4
4
Hole In Material
3
3
Migration
3
3
Failure To Adhere Or Bond
2
2
Fluid/Blood Leak
2
2
Defective Component
2
2
Split
2
2
Detachment of Device or Device Component
1
1
Material Integrity Problem
1
1
Pumping Problem
1
1
Insufficient Information
1
1
Device Handling Problem
1
1
Material Fragmentation
1
1
Material Frayed
1
1
Loose or Intermittent Connection
1
1
Device Difficult to Setup or Prepare
1
1
Difficult to Remove
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
21
21
No Clinical Signs, Symptoms or Conditions
16
16
Insufficient Information
8
8
No Known Impact Or Consequence To Patient
3
3
No Information
3
3
Unintended Radiation Exposure
3
3
Injury
1
1
Numbness
1
1
Blood Loss
1
1
Foreign Body In Patient
1
1
Air Embolism
1
1
Bacterial Infection
1
1
Dyspnea
1
1
Endocarditis
1
1
Hemorrhage/Bleeding
1
1
Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien LLC
II
Nov-24-2015
2
Covidien LLC
II
Jul-01-2015
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