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	95	95
Material Deformation	58	58
Obstruction of Flow	47	47
Adverse Event Without Identified Device or Use Problem	43	43
Material Frayed	40	40
Break	33	33
Defective Component	26	26
Material Puncture/Hole	23	23
Detachment of Device or Device Component	18	18
Difficult to Remove	15	15
Device Dislodged or Dislocated	14	14
Unraveled Material	14	14
Material Twisted/Bent	11	11
Component Incompatible	9	9
Failure to Infuse	9	9
Product Quality Problem	9	9
Material Fragmentation	8	8
Insufficient Information	6	6
Insufficient Flow or Under Infusion	6	6
Contamination /Decontamination Problem	6	6
Physical Resistance/Sticking	5	5
Suction Problem	4	4
Material Separation	3	3
Collapse	3	3
Difficult to Advance	3	3
Infusion or Flow Problem	3	3
Difficult to Insert	3	3
Material Too Rigid or Stiff	3	3
Nonstandard Device	2	2
Failure to Advance	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
Structural Problem	1	1
Defective Device	1	1
Filling Problem	1	1
Misassembled	1	1
Device Markings/Labelling Problem	1	1
Restricted Flow rate	1	1
Crack	1	1
Activation Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Migration	1	1
Fracture	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	280	280
Insufficient Information	70	70
Swelling/ Edema	48	48
Erythema	47	47
No Consequences Or Impact To Patient	46	46
Hemorrhage/Bleeding	21	21
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