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	98	98
Material Deformation	57	57
Adverse Event Without Identified Device or Use Problem	53	53
Obstruction of Flow	45	45
Material Frayed	43	43
Break	27	27
Defective Component	26	27
Material Puncture/Hole	21	23
Unraveled Material	18	18
Detachment of Device or Device Component	17	17
Difficult to Remove	14	14
Device Dislodged or Dislocated	12	12
Product Quality Problem	12	12
Component Incompatible	11	11
Failure to Infuse	11	11
Contamination /Decontamination Problem	9	9
Insufficient Flow or Under Infusion	8	8
Material Twisted/Bent	7	7
Material Fragmentation	7	7
Failure to Advance	6	6
Insufficient Information	6	6
Suction Problem	5	5
Physical Resistance/Sticking	4	4
Difficult to Insert	3	3
Material Too Rigid or Stiff	3	3
Material Separation	3	3
Entrapment of Device	3	3
Difficult to Advance	2	2
Gas/Air Leak	2	2
Infusion or Flow Problem	2	2
Material Rupture	2	2
Activation Problem	2	2
Migration or Expulsion of Device	2	2
Mechanical Problem	2	2
Nonstandard Device	2	2
Disconnection	2	2
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	2
Defective Device	1	3
Backflow	1	1
Device Difficult to Setup or Prepare	1	1
Filling Problem	1	1
Collapse	1	1
Structural Problem	1	1
Device Markings/Labelling Problem	1	1
Misassembled	1	1
Restricted Flow rate	1	1
Packaging Problem	1	1
Crack	1	1
Inadequacy of Device Shape and/or Size	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	315	316
Insufficient Information	74	76
Erythema	48	48
Swelling/ Edema	48	48
Hemorrhage/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
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
Thrombosis/Thrombus	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
Chest Pain	1	1
Renal Impairment	1	1
Extravasation	1	1
Hypoxia	1	1
Loss of consciousness	1	1
Aspiration Pneumonitis	1	1