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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubes, vials, systems, serum separators, blood collection
Regulation Description Blood specimen collection device.
Product CodeJKA
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
AVIA VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 8
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON & COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
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 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
KURIN, INC,
  SUBSTANTIALLY EQUIVALENT 1
LIFEOUTCOMES LLC
  SUBSTANTIALLY EQUIVALENT 1
MAGNOLIA MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
MAGNOLIA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NSP TECH PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
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
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
VENOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU MEDLINE INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3774 3775
2021 3610 3623
2022 3375 3391
2023 4400 4400
2024 4609 4610
2025 4952 4952

Device Problems MDRs with this Device Problem Events in those MDRs
Short Fill 4006 4006
Incorrect, Inadequate or Imprecise Result or Readings 3838 3840
Leak/Splash 2907 2908
Device Contamination with Chemical or Other Material 2808 2808
Device Ingredient or Reagent Problem 1982 1982
Volume Accuracy Problem 1479 1479
Fluid/Blood Leak 1454 1454
Coagulation in Device or Device Ingredient 923 923
Overfill 797 797
Material Deformation 797 797
Device Markings/Labelling Problem 794 794
Separation Problem 688 688
Product Quality Problem 621 626
Break 517 517
Difficult to Insert 492 492
Crack 268 268
Component Missing 265 265
Difficult or Delayed Activation 249 249
Premature Separation 222 222
Improper Chemical Reaction 205 205
Missing Information 199 199
False Positive Result 184 184
Material Discolored 142 142
Physical Resistance/Sticking 132 132
Detachment of Device or Device Component 125 125
Filling Problem 117 117
Clumping in Device or Device Ingredient 106 106
Complete Blockage 99 99
Defective Component 92 93
Fracture 92 92
Packaging Problem 89 89
Improper or Incorrect Procedure or Method 89 89
Separation Failure 88 88
Material Separation 84 84
Delivered as Unsterile Product 80 80
Material Protrusion/Extrusion 79 79
Excessive Heating 78 78
Failure to Obtain Sample 78 78
Material Twisted/Bent 69 69
Contamination 65 70
Difficult to Remove 61 61
Retraction Problem 54 54
Incorrect Measurement 50 50
Device Contamination with Body Fluid 49 49
Output Problem 47 47
Material Puncture/Hole 46 46
Inaccurate Information 37 37
Defective Device 35 35
Deformation Due to Compressive Stress 34 34
Adverse Event Without Identified Device or Use Problem 32 32

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20177 20203
No Consequences Or Impact To Patient 1844 1844
No Known Impact Or Consequence To Patient 1505 1506
No Patient Involvement 766 766
Needle Stick/Puncture 265 265
Insufficient Information 206 207
Exposure to Body Fluids 58 58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 27
Hemolysis 23 23
Pain 21 21
Discomfort 13 13
No Code Available 13 13
Foreign Body In Patient 10 10
Test Result 10 10
Hemorrhage/Bleeding 8 8
Blood Loss 7 7
Hematoma 6 6
Swelling/ Edema 5 5
Skin Inflammation/ Irritation 4 4
Extravasation 4 4
Bruise/Contusion 4 4
Abrasion 2 2
Local Reaction 2 2
Reinfusion 2 2
Inflammation 1 1
Malaise 1 1
Easy Bruising 1 1
Abnormal Blood Gases 1 1
Alteration In Body Temperature 1 1
Injury 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Thrombosis/Thrombus 1 1
Not Applicable 1 1
Hypersensitivity/Allergic reaction 1 1
Nerve Damage 1 1
Jaundice 1 1
Cardiogenic Shock 1 1
Injection Site Reaction 1 1
Laceration(s) 1 1
Radiation Underdose 1 1
Fluid Discharge 1 1
Muscle/Tendon Damage 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Pseudoaneurysm 1 1
Foreign Body Sensation in Eye 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ASP Global, LLC. dba Anatomy Supply Partners, LLC. II Oct-27-2025
2 Advance Dx, Inc. II Aug-10-2021
3 Becton Dickinson & Company II Oct-14-2022
4 Becton Dickinson & Company III Feb-23-2022
5 C.A. Greiner & Sohne Gesellschaftmbh II May-26-2020
6 Centurion Medical Products Corporation II Jul-09-2020
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 Greiner Bio-One North America, Inc. II Sep-29-2020
13 Greiner Bio-One North America, Inc. II Jan-17-2020
14 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
15 Magnolia Medical Technologies, Inc. II Dec-01-2021
16 Magnolia Medical Technologies, Inc. II Aug-31-2021
17 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
18 Radiometer Medical ApS II May-19-2022
19 Radiometer Medical ApS II May-26-2021
20 Smiths Medical ASD Inc. II Oct-20-2023
21 Smiths Medical ASD, Inc. II Apr-15-2020
22 Velano Vascular II Jan-25-2022
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