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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 1
MAGNOLIA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NSP TECH PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K193074  Bevel Up Holder
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 3774
2021 3610 3610
2022 3375 3375
2023 4400 4400
2024 4609 4609
2025 2685 2685

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3628 3628
Short Fill 3605 3605
Device Contamination with Chemical or Other Material 2669 2669
Leak/Splash 2664 2664
Device Ingredient or Reagent Problem 1689 1689
Volume Accuracy Problem 1454 1454
Fluid/Blood Leak 1330 1330
Coagulation in Device or Device Ingredient 872 872
Material Deformation 730 730
Overfill 727 727
Device Markings/Labelling Problem 702 702
Separation Problem 648 648
Product Quality Problem 535 535
Break 504 504
Difficult to Insert 425 425
Component Missing 258 258
Difficult or Delayed Activation 237 237
Crack 226 226
Missing Information 191 191
Premature Separation 161 161
Material Discolored 128 128
Detachment of Device or Device Component 122 122
Physical Resistance/Sticking 119 119
Filling Problem 112 112
Improper Chemical Reaction 109 109
Clumping in Device or Device Ingredient 98 98
Complete Blockage 90 90
Defective Component 89 89
Improper or Incorrect Procedure or Method 86 86
Packaging Problem 85 85
Material Separation 83 83
Delivered as Unsterile Product 79 79
Failure to Obtain Sample 78 78
Fracture 76 76
Material Protrusion/Extrusion 73 73
Difficult to Remove 60 60
Separation Failure 60 60
Contamination 59 59
Material Twisted/Bent 58 58
Retraction Problem 51 51
Device Contamination with Body Fluid 47 47
Output Problem 45 45
Incorrect Measurement 44 44
Material Puncture/Hole 43 43
Inaccurate Information 37 37
Deformation Due to Compressive Stress 34 34
Defective Device 32 32
Adverse Event Without Identified Device or Use Problem 31 31
Disconnection 31 31
Illegible Information 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17939 17939
No Consequences Or Impact To Patient 1844 1844
No Known Impact Or Consequence To Patient 1505 1505
No Patient Involvement 766 766
Needle Stick/Puncture 243 243
Insufficient Information 201 201
Exposure to Body Fluids 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Hemolysis 23 23
Pain 21 21
No Code Available 13 13
Discomfort 12 12
Test Result 10 10
Foreign Body In Patient 9 9
Hemorrhage/Bleeding 7 7
Blood Loss 7 7
Hematoma 6 6
Swelling/ Edema 5 5
Bruise/Contusion 4 4
Skin Inflammation/ Irritation 4 4
Extravasation 4 4
Reinfusion 2 2
Abrasion 2 2
Local Reaction 2 2
Low Blood Pressure/ Hypotension 1 1
Pseudoaneurysm 1 1
Unspecified Tissue Injury 1 1
Perforation of Vessels 1 1
Muscle/Tendon Damage 1 1
Fluid Discharge 1 1
Radiation Underdose 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Cardiogenic Shock 1 1
Jaundice 1 1
Thrombosis/Thrombus 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Injury 1 1
Alteration In Body Temperature 1 1
Easy Bruising 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 Advance Dx, Inc. II Aug-10-2021
2 Becton Dickinson & Company II Oct-14-2022
3 Becton Dickinson & Company III Feb-23-2022
4 C.A. Greiner & Sohne Gesellschaftmbh II May-26-2020
5 Centurion Medical Products Corporation II Jul-09-2020
6 Greiner Bio-One North America, Inc. II Jul-17-2024
7 Greiner Bio-One North America, Inc. II Jan-16-2024
8 Greiner Bio-One North America, Inc. II May-12-2023
9 Greiner Bio-One North America, Inc. II Jan-18-2022
10 Greiner Bio-One North America, Inc. II Sep-24-2021
11 Greiner Bio-One North America, Inc. II Sep-29-2020
12 Greiner Bio-One North America, Inc. II Jan-17-2020
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 Smiths Medical ASD, Inc. II Apr-15-2020
21 Velano Vascular II Jan-25-2022
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