• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10 10
Material Puncture/Hole 6 6
Leak/Splash 5 5
Migration 3 3
Insufficient Flow or Under Infusion 2 2
Defective Component 2 2
Detachment of Device or Device Component 1 1
Material Integrity Problem 1 1
Pumping Problem 1 1
Insufficient Information 1 1
Device Difficult to Setup or Prepare 1 1
Material Frayed 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 9 9
Insufficient Information 8 8
No Information 2 2
Unintended Radiation Exposure 2 2
Numbness 1 1
Air Embolism 1 1
Bacterial Infection 1 1
Dyspnea 1 1
Endocarditis 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1

-
-