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	92	92
Material Deformation	57	57
Obstruction of Flow	46	46
Adverse Event Without Identified Device or Use Problem	43	43
Material Frayed	39	39
Break	32	32
Defective Component	26	26
Material Puncture/Hole	23	23
Detachment of Device or Device Component	17	17
Difficult to Remove	15	15
Device Dislodged or Dislocated	12	12
Unraveled Material	12	12
Material Twisted/Bent	11	11
Component Incompatible	9	9
Failure to Infuse	9	9
Product Quality Problem	8	8
Material Fragmentation	8	8
Insufficient Information	6	6
Insufficient Flow or Under Infusion	6	6
Physical Resistance/Sticking	5	5
Contamination /Decontamination Problem	5	5
Suction Problem	4	4
Collapse	3	3
Infusion or Flow Problem	3	3
Difficult to Advance	3	3
Difficult to Insert	3	3
Material Too Rigid or Stiff	3	3
Nonstandard Device	2	2
Material Separation	2	2
Gas/Air Leak	2	2
Material Integrity Problem	2	2
Migration or Expulsion of Device	2	2
Leak/Splash	2	2
Disconnection	2	2
Device Difficult to Setup or Prepare	1	1
Backflow	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Structural Problem	1	1
Filling Problem	1	1
Device Markings/Labelling Problem	1	1
Misassembled	1	1
Restricted Flow rate	1	1
Crack	1	1
Activation Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Fracture	1	1
Mechanical Problem	1	1
Entrapment of Device	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	271	271
Insufficient Information	66	66
Swelling/ Edema	48	48
Erythema	47	47
No Consequences Or Impact To Patient	46	46
Hemorrhage/Bleeding	19	19
Foreign Body In Patient	17	17
Unintended Radiation Exposure	5	5
Hematoma	3	3
Great Vessel Perforation	3	3
Skin Inflammation/ Irritation	2	2
Exsanguination	2	2
Needle Stick/Puncture	2	2
Laceration(s)	2	2
Perforation of Vessels	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
Anaphylactoid	1	1
Obstruction/Occlusion	1	1
Cardiac Arrest	1	1
Cardiac Tamponade	1	1
No Known Impact Or Consequence To Patient	1	1
Burning Sensation	1	1
Injury	1	1
Chest Pain	1	1
Renal Impairment	1	1
Hypoxia	1	1
Loss of consciousness	1	1
Hemothorax	1	1
Aspiration Pneumonitis	1	1