TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	16	16
Migration	14	14
Leak/Splash	8	8
Material Puncture/Hole	6	6
Crack	4	4
Insufficient Flow or Under Infusion	4	4
Product Quality Problem	4	4
Hole In Material	3	3
Split	2	2
Defective Component	2	2
Fluid/Blood Leak	2	2
Material Fragmentation	2	2
Failure To Adhere Or Bond	2	2
Component Missing	2	2
Material Frayed	1	1
Pumping Problem	1	1
Insufficient Information	1	1
Material Integrity Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Detachment of Device or Device Component	1	1
Loose or Intermittent Connection	1	1
Difficult to Remove	1	1
Unraveled Material	1	1
Device Difficult to Setup or Prepare	1	1
Device Handling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23	23
No Consequences Or Impact To Patient	21	21
Insufficient Information	15	15
Unintended Radiation Exposure	4	4
No Information	3	3
No Known Impact Or Consequence To Patient	3	3
Air Embolism	1	1
Unspecified Infection	1	1
Blood Loss	1	1
Injury	1	1
Foreign Body In Patient	1	1
Rash	1	1
Numbness	1	1
Dyspnea	1	1
Pain	1	1
Endocarditis	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1