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	911	914
Fluid/Blood Leak	827	841
Disconnection	325	326
Device Contamination with Chemical or Other Material	242	242
Break	169	170
Contamination	133	134
Material Separation	132	133
Particulates	99	99
No Flow	91	91
Defective Component	75	76
Detachment of Device or Device Component	68	74
Loose or Intermittent Connection	63	66
Air/Gas in Device	56	56
Connection Problem	49	49
Infusion or Flow Problem	45	47
Separation Problem	36	36
Crack	35	35
Complete Blockage	26	26
Failure to Infuse	22	22
Difficult or Delayed Activation	21	21
Defective Device	20	20
Contamination /Decontamination Problem	20	20
Obstruction of Flow	18	18
Inflation Problem	18	18
Retraction Problem	14	14
Improper Flow or Infusion	13	13
Therapeutic or Diagnostic Output Failure	11	11
Material Protrusion/Extrusion	10	10
Nonstandard Device	9	9
Component Missing	9	9
Device Markings/Labelling Problem	9	9
Material Twisted/Bent	8	9
Insufficient Flow or Under Infusion	8	8
Backflow	8	8
Packaging Problem	7	7
Product Quality Problem	7	8
Failure to Deliver	7	7
Protective Measures Problem	7	7
Incomplete or Inadequate Connection	7	7
Activation, Positioning or Separation Problem	6	6
Material Integrity Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	8
Inaccurate Delivery	5	5
Material Deformation	5	5
Material Puncture/Hole	5	5
Restricted Flow rate	5	5
Mechanical Problem	5	5
Material Split, Cut or Torn	5	5
Free or Unrestricted Flow	4	4
Decoupling	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2949	2967
Chemical Exposure	277	279
Insufficient Information	190	208
No Consequences Or Impact To Patient	52	52
Hemorrhage/Bleeding	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Patient Involvement	3	3
Burning Sensation	1	1
Needle Stick/Puncture	1	1
Eye Injury	1	1
Muscle/Tendon Damage	1	1
Extravasation	1	1
Unspecified Tissue Injury	1	1
Cerebrospinal Fluid Leakage	1	1
Cancer	1	1