TPLC - Total Product Life Cycle

• 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
2025	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Migration	14	14
Break	12	12
Material Puncture/Hole	4	4
Insufficient Flow or Under Infusion	3	3
Product Quality Problem	3	3
Defective Component	2	2
Difficult to Remove	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Frayed	1	1
Leak/Splash	1	1
Pumping Problem	1	1
Insufficient Information	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Material Fragmentation	1	1
Unraveled Material	1	1
Device Difficult to Setup or Prepare	1	1
Detachment of Device or Device Component	1	1
Failure to Advance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	27	27
Insufficient Information	12	12
Unintended Radiation Exposure	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Consequences Or Impact To Patient	3	3
Dyspnea	2	2
Air Embolism	1	1
Unspecified Infection	1	1
Nausea	1	1
Dizziness	1	1
Malaise	1	1
Rash	1	1
Chest Pain	1	1
Numbness	1	1
Pain	1	1
Endocarditis	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1
Sore Throat	1	1
Loss of consciousness	1	1