TPLC - Total Product Life Cycle

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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

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