TPLC - Total Product Life Cycle

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Device	catheter, hemodialysis, triple lumen, non-implanted
Definition	Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Product Code	NIE
Regulation Number	876.5540
Device Class	2

Premarket Reviews
Manufacturer	Decision
HEALTH LINE INTERNATIONAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
	SUBSTANTIALLY EQUIVALENT - KIT	1
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	85	85
Material Deformation	54	54
Adverse Event Without Identified Device or Use Problem	43	43
Obstruction of Flow	43	43
Material Frayed	42	42
Break	33	33
Material Puncture/Hole	27	27
Defective Component	25	25
Detachment of Device or Device Component	20	20
Difficult to Remove	18	18
Device Dislodged or Dislocated	16	16
Material Twisted/Bent	12	12
Failure to Infuse	10	10
Product Quality Problem	10	10
Component Incompatible	10	10
Unraveled Material	8	8
Material Fragmentation	8	8
Contamination /Decontamination Problem	8	8
Leak/Splash	7	7
Insufficient Information	6	6
Physical Resistance/Sticking	6	6
Material Integrity Problem	5	5
Gas/Air Leak	5	5
Insufficient Flow or Under Infusion	5	5
Nonstandard Device	5	5
Suction Problem	4	4
Difficult to Insert	4	4
Difficult to Advance	4	4
Infusion or Flow Problem	3	3
Failure to Advance	3	3
Material Split, Cut or Torn	3	3
Collapse	3	3
Disconnection	3	3
Migration or Expulsion of Device	3	3
Material Too Rigid or Stiff	3	3
Improper or Incorrect Procedure or Method	2	2
Malposition of Device	2	2
Deformation Due to Compressive Stress	2	2
Device Markings/Labelling Problem	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Contamination of Device Ingredient or Reagent	1	1
Activation, Positioning or Separation Problem	1	1
Defective Device	1	1
Device Displays Incorrect Message	1	1
Structural Problem	1	1
Activation Problem	1	1
Material Protrusion/Extrusion	1	1
No Flow	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	246	246
Insufficient Information	60	60
No Consequences Or Impact To Patient	58	58
Swelling/ Edema	48	48
Erythema	47	47
No Known Impact Or Consequence To Patient	30	30
Foreign Body In Patient	15	15
Hemorrhage/Bleeding	15	15
Death	7	7
Hematoma	6	6
Unintended Radiation Exposure	5	5
No Patient Involvement	4	4
Blood Loss	3	3
No Information	2	2
Exsanguination	2	2
Cardiac Arrest	2	2
Laceration(s)	2	2
Perforation of Vessels	2	2
Great Vessel Perforation	2	2
Abdominal Pain	1	1
Air Embolism	1	1
Encephalopathy	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Arrhythmia	1	1
Fatigue	1	1
Radiation Exposure, Unintended	1	1
Skin Inflammation/ Irritation	1	1
Anaphylactoid	1	1
Obstruction/Occlusion	1	1
Cardiac Tamponade	1	1
Injury	1	1
Cardiac Perforation	1	1
Renal Impairment	1	1
Hypoxia	1	1
Loss of consciousness	1	1
Hemothorax	1	1
Thrombus	1	1
Device Embedded In Tissue or Plaque	1	1
Aspiration Pneumonitis	1	1