TPLC - Total Product Life Cycle

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Device	stopcock, i.v. set
Regulation Description	Intravascular administration set.
Product Code	FMG
Regulation Number	880.5440
Device Class	2

Premarket Reviews
Manufacturer	Decision
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ELCAM MEDICAL ACAL
	SUBSTANTIALLY EQUIVALENT	1
M/S ROMSONS INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
1. K223499 Three Way Stop Cock
MEDEX
	SUBSTANTIALLY EQUIVALENT	1
YOMURA TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1138	1138
Leak/Splash	402	402
Disconnection	261	261
No Flow	204	204
Crack	194	194
Break	140	140
Device Contamination with Chemical or Other Material	123	123
Material Separation	122	122
Air/Gas in Device	99	99
Loose or Intermittent Connection	52	52
Infusion or Flow Problem	47	47
Connection Problem	46	46
Particulates	46	46
Separation Problem	42	42
Detachment of Device or Device Component	38	38
Backflow	35	35
Defective Component	32	32
Obstruction of Flow	20	20
Material Split, Cut or Torn	19	19
Complete Blockage	17	17
Contamination	15	15
Fitting Problem	15	15
Difficult to Open or Close	14	14
Fracture	14	14
Packaging Problem	14	14
Physical Resistance/Sticking	10	10
Material Puncture/Hole	10	10
Excess Flow or Over-Infusion	10	10
Incomplete or Inadequate Connection	8	8
Separation Failure	8	8
Free or Unrestricted Flow	8	8
Device Markings/Labelling Problem	7	7
Inaccurate Delivery	7	7
Material Deformation	7	7
Delivered as Unsterile Product	7	7
Material Twisted/Bent	7	7
Unsealed Device Packaging	6	6
Insufficient Flow or Under Infusion	6	6
Gas/Air Leak	6	6
Defective Device	5	5
Material Rupture	5	5
Inaccurate Flow Rate	5	5
Mechanical Jam	4	4
Mechanical Problem	4	4
Component Missing	4	4
Inaccurate Information	3	3
Failure to Deliver	3	3
Microbial Contamination of Device	3	3
Difficult to Remove	3	3
Precipitate in Device or Device Ingredient	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2185	2185
No Consequences Or Impact To Patient	221	221
Insufficient Information	103	103
Chemical Exposure	102	102
Low Blood Pressure/ Hypotension	72	72
No Known Impact Or Consequence To Patient	63	63
Hemorrhage/Bleeding	44	44
No Patient Involvement	38	38
Air Embolism	8	8
High Blood Pressure/ Hypertension	8	8
Blood Loss	8	8
Awareness during Anaesthesia	7	7
Hypoglycemia	6	6
Low Oxygen Saturation	5	5
Sepsis	5	5
Tachycardia	5	5
Cardiac Arrest	5	5
Death	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Irritability	3	3
No Information	3	3
Ventricular Fibrillation	3	3
Skin Burning Sensation	2	2
Loss of consciousness	2	2
Discomfort	2	2
Exposure to Body Fluids	2	2
Emotional Changes	2	2
Stroke/CVA	2	2
Thrombosis/Thrombus	1	1
Loss Of Pulse	1	1
Burning Sensation	1	1
Overdose	1	1
Cardiogenic Shock	1	1
Blister	1	1
Cardiopulmonary Arrest	1	1
Embolism/Embolus	1	1
Malaise	1	1
Anxiety	1	1
Shaking/Tremors	1	1
Radiation Overdose	1	1
Hypoxia	1	1
Underdose	1	1
Missed Dose	1	1
Hypersensitivity/Allergic reaction	1	1
Bacterial Infection	1	1
Infiltration into Tissue	1	1
Patient Problem/Medical Problem	1	1
Weight Changes	1	1
Ventilator Dependent	1	1
Respiratory Failure	1	1