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	102	102
Material Deformation	66	66
Adverse Event Without Identified Device or Use Problem	55	55
Material Frayed	49	49
Obstruction of Flow	46	46
Break	27	27
Defective Component	25	25
Material Puncture/Hole	20	20
Detachment of Device or Device Component	17	17
Unraveled Material	16	16
Difficult to Remove	15	15
Product Quality Problem	14	14
Device Dislodged or Dislocated	13	13
Component Incompatible	11	11
Failure to Infuse	11	11
Contamination /Decontamination Problem	10	10
Material Fragmentation	8	8
Insufficient Flow or Under Infusion	8	8
Material Twisted/Bent	7	7
Insufficient Device Problem Information	6	6
Suction Problem	5	5
Difficult to Advance	3	3
Material Separation	3	3
Material Too Rigid or Stiff	3	3
Infusion or Flow Problem	3	3
Nonstandard Device	2	2
Failure to Advance	2	2
Fracture	2	2
Material Integrity Problem	2	2
Activation Problem	2	2
Physical Resistance/Sticking	2	2
Migration or Expulsion of Device	2	2
Entrapment of Device	2	2
Disconnection	2	2
Misassembled	1	1
Material Rupture	1	1
Backflow	1	1
Difficult to Insert	1	1
Filling Problem	1	1
Migration	1	1
Device Markings/Labelling Problem	1	1
Restricted Flow rate	1	1
Crack	1	1
Material Too Soft/Flexible	1	1
Improper or Incorrect Procedure or Method	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	322	327
Insufficient Information	78	80
Swelling/ Edema	49	49
Erythema	49	49
No Consequences Or Impact To Patient	46	46
Hemorrhage/Blood Loss/Bleeding	25	25
Foreign Body In Patient	20	20
Unintended Radiation Exposure	5	5
Great Vessel Perforation	5	5
Hemothorax	3	3
Perforation of Vessels	3	3
Laceration(s)	3	3
Hematoma	3	3
Skin Inflammation/ Irritation	3	3
Cardiac Arrest	2	2
Cardiac Tamponade	2	2
Needle Stick/Puncture	2	2
Thrombosis/Thrombus	2	2
Exsanguination	2	2
Stenosis	2	2
Arrhythmia	2	2
Unspecified Infection	2	2
Air Embolism	2	2
Embolism/Embolus	1	1
Obstruction/Occlusion	1	1
No Known Impact Or Consequence To Patient	1	1
High White Blood Cell Count	1	1
Burning Sensation	1	1
Injury	1	1
Chest Pain	1	1
Radiation Exposure, Unintended	1	1
Fatigue	1	1
Renal Impairment	1	1
Anaphylactoid / Anaphylaxis	1	1
Extravasation	1	1
Hypersensitivity/Allergic reaction	1	1
Hypoxia	1	1
Encephalopathy	1	1
Loss of consciousness	1	1
Aspiration Pneumonitis	1	1
Abdominal Pain	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1