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	15
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	1
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
ZHEJIANG KINDLY MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Short Fill	4607	4607
Incorrect, Inadequate or Imprecise Result or Readings	3389	3390
Device Contamination with Chemical or Other Material	2469	2470
Device Ingredient or Reagent Problem	2329	2329
Leak/Splash	2155	2155
Fluid/Blood Leak	1979	1980
Volume Accuracy Problem	880	880
Overfill	850	850
Separation Problem	830	830
Coagulation in Device or Device Ingredient	794	794
Device Markings/Labelling Problem	730	730
Material Deformation	671	671
Product Quality Problem	575	575
Difficult to Insert	503	503
Break	486	486
Improper Chemical Reaction	392	392
Difficult or Delayed Activation	342	342
Crack	332	332
Detachment of Device or Device Component	305	305
Premature Separation	277	277
Component Missing	260	260
Missing Information	207	207
False Positive Result	187	187
Material Discolored	156	156
Separation Failure	154	154
Physical Resistance/Sticking	139	139
Material Separation	114	114
Clumping in Device or Device Ingredient	109	109
Filling Problem	102	102
Fracture	101	101
Complete Blockage	87	88
Defective Component	84	85
Contamination	83	83
Packaging Problem	81	81
Excessive Heating	79	79
Failure to Obtain Sample	79	79
Retraction Problem	77	78
Material Twisted/Bent	75	75
Material Protrusion/Extrusion	69	69
Improper or Incorrect Procedure or Method	66	66
Difficult to Remove	62	62
Delivered as Unsterile Product	59	59
Loss of or Failure to Bond	57	57
Material Puncture/Hole	44	44
Incorrect Measurement	40	40
Device Contamination with Body Fluid	38	38
Inaccurate Information	37	37
Output Problem	36	36
Use of Device Problem	35	35
Deformation Due to Compressive Stress	34	34

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24800	24830
No Consequences Or Impact To Patient	538	538
Needle Stick/Puncture	289	290
Insufficient Information	174	175
Exposure to Body Fluids	66	66
No Patient Involvement	30	30
Pain	28	28
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	19	21
Discomfort	13	13
Foreign Body In Patient	12	12
Hemorrhage/Blood Loss/Bleeding	10	10
Hyperkalemia	7	7
Hemolysis	6	6
Hematoma	6	6
Swelling/ Edema	5	5
No Known Impact Or Consequence To Patient	5	5
Bruise/Contusion	4	4
Skin Inflammation/ Irritation	4	4
Fever	4	4
Extravasation	4	4
Chills	3	3
Diaphoresis	2	2
Hypocalcemia	2	2
Hot Flashes/Flushes	2	2
Local Reaction	2	2
Unspecified Tissue Injury	2	2
Alteration in Body Temperature	2	2
Altered State of Consciousness	1	1
Reduced Blood Flow	1	1
Low Blood Pressure/ Hypotension	1	1
Perforation of Vessels	1	1
Muscle/Tendon Damage	1	1
Fluid Discharge	1	1
Pneumonia	1	1
Scar Tissue	1	1
Laceration(s)	1	1
Dehydration	1	1
Cardiogenic Shock	1	1
Nerve Damage	1	1
Thrombosis/Thrombus	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Easy Bruising	1	1
Abrasion	1	1
Malaise	1	1
Inflammation	1	1
Abnormal Blood Gases	1	1
Not Applicable	1	1
Hypersensitivity/Allergic reaction	1	1
Injection Site Reaction	1	1
Foreign Body Sensation in Eye	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