TPLC - Total Product Life Cycle

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Device	closed antineoplastic and hazardous drug reconstitution and transfer system
Regulation Description	Intravascular administration set.
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	9
EQUASHIELD MEDICAL LTD.
	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	867	867
Fluid/Blood Leak	637	636
Device Contamination with Chemical or Other Material	289	289
Disconnection	181	181
Break	156	156
Material Separation	110	110
Detachment of Device or Device Component	57	60
Loose or Intermittent Connection	57	56
Particulates	53	53
Infusion or Flow Problem	49	49
Contamination	48	48
Air/Gas in Device	40	40
Defective Component	37	37
Difficult or Delayed Activation	36	36
No Flow	35	35
Crack	29	29
Complete Blockage	29	29
Separation Problem	22	22
Failure to Infuse	18	18
Improper Flow or Infusion	11	11
Contamination /Decontamination Problem	11	11
Retraction Problem	10	10
Obstruction of Flow	10	10
Packaging Problem	9	9
Defective Device	9	9
Connection Problem	9	9
Incomplete or Inadequate Connection	8	8
Device Markings/Labelling Problem	8	8
Component Missing	8	8
Material Twisted/Bent	7	7
Mechanical Problem	6	6
Insufficient Flow or Under Infusion	6	6
Restricted Flow rate	5	5
Material Puncture/Hole	5	5
Excess Flow or Over-Infusion	5	5
Decoupling	4	4
Material Protrusion/Extrusion	4	4
Inaccurate Delivery	4	4
Protective Measures Problem	4	4
Backflow	4	4
Device Difficult to Setup or Prepare	3	3
Fail-Safe Problem	3	3
Failure to Deliver	3	3
Premature Separation	3	3
Unsealed Device Packaging	3	3
Material Deformation	3	3
Volume Accuracy Problem	3	3
Burst Container or Vessel	3	3
Product Quality Problem	3	3
Material Split, Cut or Torn	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2047	2049
No Consequences Or Impact To Patient	248	248
Chemical Exposure	242	242
Insufficient Information	145	145
No Known Impact Or Consequence To Patient	117	117
No Patient Involvement	79	79
Hemorrhage/Bleeding	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Information	3	3
Blood Loss	3	3
Underdose	2	2
Skin Irritation	1	1
Needle Stick/Puncture	1	1
Swelling	1	1
Eye Injury	1	1
Muscle/Tendon Damage	1	1
Extravasation	1	1
Unspecified Tissue Injury	1	1