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	8
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	840	840
Fluid/Blood Leak	595	594
Device Contamination with Chemical or Other Material	287	287
Disconnection	165	165
Break	149	149
Material Separation	98	98
Detachment of Device or Device Component	57	60
Loose or Intermittent Connection	56	55
Contamination	44	44
Infusion or Flow Problem	42	42
Particulates	41	41
Air/Gas in Device	39	39
Difficult or Delayed Activation	36	36
Defective Component	34	34
No Flow	31	31
Complete Blockage	29	29
Crack	28	28
Separation Problem	21	21
Failure to Infuse	18	18
Contamination /Decontamination Problem	11	11
Improper Flow or Infusion	11	11
Retraction Problem	10	10
Obstruction of Flow	10	10
Incomplete or Inadequate Connection	8	8
Packaging Problem	8	8
Device Markings/Labelling Problem	8	8
Defective Device	8	8
Connection Problem	7	7
Material Twisted/Bent	7	7
Mechanical Problem	6	6
Insufficient Flow or Under Infusion	6	6
Component Missing	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	1911	1913
No Consequences Or Impact To Patient	248	248
Chemical Exposure	229	229
Insufficient Information	135	135
No Known Impact Or Consequence To Patient	117	117
No Patient Involvement	79	79
Hemorrhage/Bleeding	6	6
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
Unspecified Tissue Injury	1	1
Extravasation	1	1