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
YOMURA TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1101	1101
Leak/Splash	396	396
Disconnection	256	256
No Flow	197	197
Crack	185	185
Break	137	137
Material Separation	120	120
Device Contamination with Chemical or Other Material	120	120
Air/Gas in Device	99	99
Loose or Intermittent Connection	52	52
Particulates	46	46
Infusion or Flow Problem	46	46
Connection Problem	46	46
Separation Problem	40	40
Detachment of Device or Device Component	38	38
Backflow	34	34
Defective Component	31	31
Obstruction of Flow	20	20
Material Split, Cut or Torn	16	16
Complete Blockage	15	15
Difficult to Open or Close	14	14
Packaging Problem	14	14
Fitting Problem	14	14
Fracture	13	13
Contamination	13	13
Material Puncture/Hole	10	10
Physical Resistance/Sticking	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	2116	2116
No Consequences Or Impact To Patient	221	221
Chemical Exposure	102	102
Insufficient Information	100	100
Low Blood Pressure/ Hypotension	72	72
No Known Impact Or Consequence To Patient	63	63
Hemorrhage/Bleeding	41	41
No Patient Involvement	38	38
Air Embolism	8	8
High Blood Pressure/ Hypertension	8	8
Blood Loss	8	8
Hypoglycemia	6	6
Low Oxygen Saturation	5	5
Tachycardia	5	5
Awareness during Anaesthesia	5	5
Sepsis	5	5
Cardiac Arrest	5	5
Death	4	4
No Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Ventricular Fibrillation	2	2
Exposure to Body Fluids	2	2
Discomfort	2	2
Emotional Changes	2	2
Stroke/CVA	2	2
Loss of consciousness	2	2
Skin Burning Sensation	2	2
Blister	1	1
Embolism/Embolus	1	1
Malaise	1	1
Overdose	1	1
Burning Sensation	1	1
Loss Of Pulse	1	1
Thrombosis/Thrombus	1	1
Missed Dose	1	1
Cardiogenic Shock	1	1
Cardiopulmonary Arrest	1	1
Hypersensitivity/Allergic reaction	1	1
Shaking/Tremors	1	1
Radiation Overdose	1	1
Hypoxia	1	1
Underdose	1	1
Patient Problem/Medical Problem	1	1
Weight Changes	1	1
Bacterial Infection	1	1
Infiltration into Tissue	1	1
Irritability	1	1
Extreme Exhaustion	1	1
Ventilator Dependent	1	1
Respiratory Failure	1	1