TPLC - Total Product Life Cycle

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Device	tubes, vials, systems, serum separators, blood collection
Regulation Description	Blood specimen collection device.
Product Code	JKA
Regulation Number	862.1675
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
AVIA VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BECTON, DICKINSON & COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	11
CHIRANA T. INJECTA
	SUBSTANTIALLY EQUIVALENT	1
ECLIPSE MEDCORP, LLC
	SUBSTANTIALLY EQUIVALENT	1
GREINER BIO-ONE NORTH AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU RONGYE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KURIN, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIFEOUTCOMES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MAGNOLIA MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
OWEN MUMFORD, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RETRACTABLE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SB-KAWASUMI LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
SOL-MILLENNIUM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
THE MONARCH COMPANY
	SUBSTANTIALLY EQUIVALENT	1
VELANO VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
VENOCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU MEDLINE INDUSTRY, CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Short Fill	3732	3732
Incorrect, Inadequate or Imprecise Result or Readings	3106	3108
Device Ingredient or Reagent Problem	2313	2313
Device Contamination with Chemical or Other Material	2306	2307
Leak/Splash	2121	2121
Fluid/Blood Leak	1590	1591
Volume Accuracy Problem	874	874
Coagulation in Device or Device Ingredient	792	792
Separation Problem	759	759
Overfill	696	696
Material Deformation	651	651
Device Markings/Labelling Problem	629	629
Product Quality Problem	592	597
Difficult to Insert	500	500
Break	487	487
Improper Chemical Reaction	321	321
Crack	320	320
Premature Separation	255	255
Component Missing	243	243
Difficult or Delayed Activation	215	215
Missing Information	202	202
False Positive Result	188	188
Material Discolored	156	156
Separation Failure	155	155
Physical Resistance/Sticking	135	135
Detachment of Device or Device Component	127	127
Filling Problem	111	111
Clumping in Device or Device Ingredient	109	109
Fracture	98	98
Defective Component	91	92
Material Separation	83	83
Complete Blockage	83	84
Contamination	81	86
Failure to Obtain Sample	80	80
Packaging Problem	78	78
Excessive Heating	78	78
Material Twisted/Bent	72	72
Material Protrusion/Extrusion	69	69
Improper or Incorrect Procedure or Method	66	66
Difficult to Remove	63	63
Delivered as Unsterile Product	60	60
Retraction Problem	57	58
Output Problem	47	47
Material Puncture/Hole	46	46
Incorrect Measurement	40	40
Device Contamination with Body Fluid	39	39
Inaccurate Information	37	37
Deformation Due to Compressive Stress	34	34
Disconnection	31	31
Component Misassembled	30	30

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	22029	22059
No Consequences Or Impact To Patient	538	538
Needle Stick/Puncture	249	250
Insufficient Information	161	162
Exposure to Body Fluids	51	51
No Patient Involvement	30	30
Pain	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	21
Discomfort	13	13
Foreign Body In Patient	10	10
Hemorrhage/Bleeding	9	9
Hematoma	6	6
Hemolysis	6	6
No Known Impact Or Consequence To Patient	5	5
Swelling/ Edema	5	5
Skin Inflammation/ Irritation	4	4
Bruise/Contusion	4	4
Extravasation	4	4
Local Reaction	2	2
Perforation of Vessels	1	1
Cardiogenic Shock	1	1
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Inflammation	1	1
Nerve Damage	1	1
Foreign Body Sensation in Eye	1	1
Abnormal Blood Gases	1	1
Abrasion	1	1
Easy Bruising	1	1
Unspecified Tissue Injury	1	1
Injection Site Reaction	1	1
Not Applicable	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Thrombosis/Thrombus	1	1
Muscle/Tendon Damage	1	1
Malaise	1	1
Fluid Discharge	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ASP Global, LLC. dba Anatomy Supply Partners, LLC.	II	Nov-19-2025
2	ASP Global, LLC. dba Anatomy Supply Partners, LLC.	II	Oct-27-2025
3	Advance Dx, Inc.	II	Aug-10-2021
4	Becton Dickinson & Company	II	Oct-14-2022
5	Becton Dickinson & Company	III	Feb-23-2022
6	Greiner Bio-One North America, Inc.	II	Nov-19-2025
7	Greiner Bio-One North America, Inc.	II	Jul-17-2024
8	Greiner Bio-One North America, Inc.	II	Jan-16-2024
9	Greiner Bio-One North America, Inc.	II	May-12-2023
10	Greiner Bio-One North America, Inc.	II	Jan-18-2022
11	Greiner Bio-One North America, Inc.	II	Sep-24-2021
12	ICU Medical Inc.	II	Jan-15-2026
13	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
14	Magnolia Medical Technologies, Inc.	II	Dec-01-2021
15	Magnolia Medical Technologies, Inc.	II	Aug-31-2021
16	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
17	Radiometer Medical ApS	II	May-19-2022
18	Radiometer Medical ApS	II	May-26-2021
19	Smiths Medical ASD Inc.	II	Oct-20-2023
20	Velano Vascular	II	Jan-25-2022