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	94	94
Adverse Event Without Identified Device or Use Problem	53	53
Material Deformation	51	51
Obstruction of Flow	45	45
Material Frayed	38	38
Break	27	27
Defective Component	26	27
Material Puncture/Hole	21	23
Unraveled Material	17	17
Detachment of Device or Device Component	17	17
Difficult to Remove	14	14
Device Dislodged or Dislocated	12	12
Product Quality Problem	11	11
Component Incompatible	10	10
Failure to Infuse	10	10
Contamination /Decontamination Problem	8	8
Material Fragmentation	7	7
Material Twisted/Bent	7	7
Insufficient Flow or Under Infusion	7	7
Insufficient Information	6	6
Physical Resistance/Sticking	4	4
Suction Problem	4	4
Failure to Advance	4	4
Entrapment of Device	3	3
Difficult to Insert	3	3
Material Too Rigid or Stiff	3	3
Material Separation	3	3
Disconnection	2	2
Migration or Expulsion of Device	2	2
Activation Problem	2	2
Difficult to Advance	2	2
Nonstandard Device	2	2
Gas/Air Leak	2	2
Infusion or Flow Problem	2	2
Noise, Audible	1	1
No Flow	1	1
Device Displays Incorrect Message	1	1
Improper or Incorrect Procedure or Method	1	1
Material Too Soft/Flexible	1	1
Migration	1	1
Misassembled	1	1
Structural Problem	1	1
Device Difficult to Setup or Prepare	1	1
Backflow	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	2
Defective Device	1	3
Filling Problem	1	1
Collapse	1	1
Device Markings/Labelling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	294	295
Insufficient Information	72	74
Erythema	48	48
Swelling/ Edema	48	48
Hemorrhage/Bleeding	24	24
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
Air Embolism	2	2
Unspecified Infection	2	2
Arrhythmia	2	2
Skin Inflammation/ Irritation	2	2
Exsanguination	2	2
Cardiac Arrest	2	2
Cardiac Tamponade	2	2
Needle Stick/Puncture	2	2
Laceration(s)	2	2
Stenosis	2	2
Hemothorax	2	2
Abdominal Pain	1	1
Encephalopathy	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Fatigue	1	1
Embolism/Embolus	1	1
Anaphylactoid	1	1
Obstruction/Occlusion	1	1
Burning Sensation	1	1
Thrombosis/Thrombus	1	1
Chest Pain	1	1
Renal Impairment	1	1
Hypoxia	1	1
Loss of consciousness	1	1
Aspiration Pneumonitis	1	1