TPLC - Total Product Life Cycle

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Device	subcutaneous implanted apheresis port
Definition	A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis
Product Code	PTD
Regulation Number	880.5965
Device Class	2

Premarket Reviews
Manufacturer	Decision
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
NORFOLK MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Suction Problem	26	26
Restricted Flow rate	21	21
Obstruction of Flow	18	18
Adverse Event Without Identified Device or Use Problem	12	12
Appropriate Term/Code Not Available	12	12
Fluid/Blood Leak	11	11
Difficult to Flush	10	10
Blocked Connection	10	10
Failure to Infuse	7	7
Reflux within Device	5	5
Fracture	4	4
Device Tipped Over	3	3
Device Dislodged or Dislocated	3	3
Expulsion	2	2
Migration	2	2
Material Puncture/Hole	2	2
Loss of or Failure to Bond	2	2
Material Separation	2	2
Improper or Incorrect Procedure or Method	2	2
Deformation Due to Compressive Stress	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Difficult to Open or Close	1	1
Complete Blockage	1	1
Disconnection	1	1
Device Appears to Trigger Rejection	1	1
Migration or Expulsion of Device	1	1
Unsealed Device Packaging	1	1
Material Split, Cut or Torn	1	1
Illegible Information	1	1
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	47	47
No Consequences Or Impact To Patient	36	36
Unspecified Infection	7	7
Skin Erosion	6	6
Pain	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Sepsis	4	4
Hemorrhage/Bleeding	2	2
Injury	1	1
Numbness	1	1
Obstruction/Occlusion	1	1
Palpitations	1	1
Scar Tissue	1	1
Bruise/Contusion	1	1
Fever	1	1
Hematoma	1	1
Thrombus	1	1
Weakness	1	1
Burning Sensation	1	1
Chills	1	1