TPLC - Total Product Life Cycle

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Device	closed antineoplastic and hazardous drug reconstitution and transfer system
Definition	Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
Product Code	ONB
Regulation Number	880.5440
Device Class	2

Premarket Reviews
Manufacturer	Decision
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION
	SUBSTANTIALLY EQUIVALENT	2
EPIC MEDICAL PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
EPIC MEDICAL PTE. LTD.
	SUBSTANTIALLY EQUIVALENT	5
EQUASHIELD MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
ICU MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIMPLIVIA HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	4
YUKON MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	1006	1006
Fluid/Blood Leak	595	594
Device Contamination with Chemical or Other Material	319	319
Break	147	147
Disconnection	145	145
Material Separation	89	89
Infusion or Flow Problem	87	87
Detachment of Device or Device Component	61	64
Loose or Intermittent Connection	53	52
Difficult or Delayed Activation	51	51
Contamination	43	43
Air/Gas in Device	37	37
Particulates	36	36
Defective Component	29	29
Crack	28	28
Complete Blockage	26	26
No Flow	25	25
Separation Problem	21	21
Contamination /Decontamination Problem	18	18
Failure to Infuse	17	17
Retraction Problem	12	12
Improper Flow or Infusion	11	11
Connection Problem	10	10
Incomplete or Inadequate Connection	9	9
Device Markings/Labelling Problem	9	9
Packaging Problem	9	9
Obstruction of Flow	8	8
Defective Device	8	8
Material Twisted/Bent	7	7
Material Protrusion/Extrusion	6	6
Mechanical Problem	6	6
Protective Measures Problem	6	6
Material Puncture/Hole	5	5
Product Quality Problem	5	5
Restricted Flow rate	5	5
Physical Resistance/Sticking	5	5
Insufficient Flow or Under Infusion	5	5
Excess Flow or Over-Infusion	5	5
Component Missing	5	5
Decoupling	4	4
Free or Unrestricted Flow	4	4
Material Deformation	4	4
Failure to Deliver	4	4
Inaccurate Delivery	4	4
Backflow	4	4
Device Difficult to Setup or Prepare	4	4
Contamination of Device Ingredient or Reagent	3	3
Delivered as Unsterile Product	3	3
Activation Failure	3	3
Structural Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1700	1702
No Known Impact Or Consequence To Patient	432	432
No Consequences Or Impact To Patient	311	311
Chemical Exposure	245	245
Insufficient Information	125	125
No Patient Involvement	110	110
No Information	21	21
Needle Stick/Puncture	5	5
Hemorrhage/Bleeding	5	5
Pain	4	4
Underdose	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Blood Loss	3	3
No Code Available	2	2
Exposure to Body Fluids	2	2
High Blood Pressure/ Hypertension	1	1
Skin Irritation	1	1
Chest Tightness/Pressure	1	1
Rash	1	1
Injury	1	1
Swelling	1	1
Fall	1	1
Eye Injury	1	1
Muscle/Tendon Damage	1	1
Tachycardia	1	1
Unspecified Tissue Injury	1	1
Hemorrhage, Subarachnoid	1	1