TPLC - Total Product Life Cycle

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Device	catheter, hemodialysis, triple lumen, non-implanted
Regulation Description	Blood access device and accessories.
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	96	96
Material Deformation	56	56
Adverse Event Without Identified Device or Use Problem	53	53
Obstruction of Flow	45	45
Material Frayed	41	41
Defective Component	25	25
Break	21	21
Material Puncture/Hole	18	18
Detachment of Device or Device Component	16	16
Unraveled Material	16	16
Difficult to Remove	13	13
Product Quality Problem	12	12
Component Incompatible	11	11
Device Dislodged or Dislocated	11	11
Failure to Infuse	11	11
Contamination /Decontamination Problem	9	9
Insufficient Flow or Under Infusion	8	8
Material Fragmentation	7	7
Insufficient Device Problem Information	6	6
Material Twisted/Bent	6	6
Suction Problem	5	5
Material Too Rigid or Stiff	3	3
Material Separation	3	3
Activation Problem	2	2
Physical Resistance/Sticking	2	2
Infusion or Flow Problem	2	2
Difficult to Advance	2	2
Failure to Advance	2	2
Nonstandard Device	2	2
Migration or Expulsion of Device	2	2
Entrapment of Device	2	2
Disconnection	2	2
Improper or Incorrect Procedure or Method	1	1
Material Rupture	1	1
Misassembled	1	1
Device Markings/Labelling Problem	1	1
Difficult to Insert	1	1
Fracture	1	1
Restricted Flow rate	1	1
Material Integrity Problem	1	1
Filling Problem	1	1
No Flow	1	1
Migration	1	1
Material Too Soft/Flexible	1	1
Crack	1	1
Backflow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	317	318
Insufficient Information	74	76
Swelling/ Edema	48	48
Erythema	48	48
Hemorrhage/Blood Loss/Bleeding	25	25
Foreign Body In Patient	15	15
No Consequences Or Impact To Patient	8	8
Unintended Radiation Exposure	4	4
Hematoma	3	3
Perforation of Vessels	3	3
Great Vessel Perforation	3	3
Arrhythmia	2	2
Cardiac Arrest	2	2
Hemothorax	2	2
Exsanguination	2	2
Thrombosis/Thrombus	2	2
Cardiac Tamponade	2	2
Laceration(s)	2	2
Skin Inflammation/ Irritation	2	2
Stenosis	2	2
Unspecified Infection	2	2
Air Embolism	2	2
Needle Stick/Puncture	2	2
Abdominal Pain	1	1
Hypersensitivity/Allergic reaction	1	1
Extravasation	1	1
Encephalopathy	1	1
Renal Impairment	1	1
High White Blood Cell Count	1	1
Burning Sensation	1	1
Chest Pain	1	1
Embolism/Embolus	1	1
Anaphylactoid / Anaphylaxis	1	1
Fatigue	1	1
Aspiration Pneumonitis	1	1
Obstruction/Occlusion	1	1
Loss of consciousness	1	1
Hypoxia	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1