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
CARE FUSION
	SUBSTANTIALLY EQUIVALENT	1
EPIC MEDICAL PTE. , LTD.
	SUBSTANTIALLY EQUIVALENT	11
EQUASHIELD MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIMPLIVIA HEALTHCARE , LTD.
	SUBSTANTIALLY EQUIVALENT	5
YUKON MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	862	865
Fluid/Blood Leak	774	788
Disconnection	296	297
Device Contamination with Chemical or Other Material	240	240
Break	162	163
Material Separation	130	131
Contamination	124	125
Particulates	98	98
No Flow	81	81
Defective Component	74	75
Detachment of Device or Device Component	66	72
Loose or Intermittent Connection	63	66
Air/Gas in Device	54	54
Infusion or Flow Problem	42	44
Connection Problem	39	39
Separation Problem	35	35
Crack	33	33
Complete Blockage	26	26
Failure to Infuse	22	22
Difficult or Delayed Activation	21	21
Contamination /Decontamination Problem	20	20
Inflation Problem	18	18
Defective Device	18	18
Obstruction of Flow	17	17
Retraction Problem	14	14
Improper Flow or Infusion	13	13
Material Protrusion/Extrusion	10	10
Therapeutic or Diagnostic Output Failure	10	10
Device Markings/Labelling Problem	9	9
Nonstandard Device	9	9
Component Missing	9	9
Insufficient Flow or Under Infusion	8	8
Material Twisted/Bent	8	9
Packaging Problem	7	7
Backflow	7	7
Failure to Deliver	7	7
Activation, Positioning or Separation Problem	6	6
Protective Measures Problem	6	6
Inaccurate Delivery	5	5
Material Split, Cut or Torn	5	5
Mechanical Problem	5	5
Material Integrity Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	8
Incomplete or Inadequate Connection	5	5
Restricted Flow rate	5	5
Material Puncture/Hole	5	5
Free or Unrestricted Flow	4	4
Fracture	4	4
Fail-Safe Problem	4	4
Product Quality Problem	4	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2806	2824
Chemical Exposure	265	267
Insufficient Information	190	208
No Consequences Or Impact To Patient	52	52
Hemorrhage/Bleeding	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Patient Involvement	3	3
Needle Stick/Puncture	1	1
Burning Sensation	1	1
Eye Injury	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Extravasation	1	1
Cerebrospinal Fluid Leakage	1	1
Cancer	1	1