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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 6
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 1
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SB-KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE MONARCH COMPANY
  SUBSTANTIALLY EQUIVALENT 1
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
VELANO VASCULAR
  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 4399 4399
2024 4608 4609
2025 350 350

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3340 3341
Short Fill 3247 3247
Device Contamination with Chemical or Other Material 2448 2448
Leak/Splash 2280 2280
Device Ingredient or Reagent Problem 1468 1468
Volume Accuracy Problem 1432 1432
Fluid/Blood Leak 1243 1243
Coagulation in Device or Device Ingredient 803 803
Overfill 640 640
Device Markings/Labelling Problem 621 621
Separation Problem 618 618
Material Deformation 615 615
Break 478 478
Product Quality Problem 395 395
Difficult to Insert 338 338
Component Missing 240 240
Difficult or Delayed Activation 223 223
Missing Information 184 184
Crack 175 175
Premature Separation 116 116
Filling Problem 112 112
Material Discolored 110 110
Detachment of Device or Device Component 109 109
Physical Resistance/Sticking 108 108
Clumping in Device or Device Ingredient 87 87
Improper or Incorrect Procedure or Method 85 85
Complete Blockage 81 81
Defective Component 81 81
Material Separation 80 80
Delivered as Unsterile Product 78 78
Packaging Problem 77 77
Failure to Obtain Sample 75 75
Fracture 67 67
Material Protrusion/Extrusion 63 63
Difficult to Remove 59 59
Separation Failure 54 54
Contamination 52 52
Material Twisted/Bent 50 50
Improper Chemical Reaction 47 47
Retraction Problem 46 46
Device Contamination with Body Fluid 43 43
Output Problem 43 43
Incorrect Measurement 43 43
Material Puncture/Hole 42 42
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
Component Misassembled 26 26
Illegible Information 25 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15655 15656
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 211 211
Insufficient Information 192 192
Exposure to Body Fluids 51 51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Hemolysis 22 22
Pain 15 15
No Code Available 13 13
Discomfort 12 12
Test Result 10 10
Foreign Body In Patient 7 7
Blood Loss 7 7
Hematoma 5 5
Hemorrhage/Bleeding 5 5
Swelling/ Edema 5 5
Extravasation 4 4
Skin Inflammation/ Irritation 4 4
Abrasion 2 2
Reinfusion 2 2
Local Reaction 2 2
Laceration(s) 1 1
Malaise 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Injection Site Reaction 1 1
Nerve Damage 1 1
Thrombosis/Thrombus 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Muscle/Tendon Damage 1 1
Bruise/Contusion 1 1
Cardiogenic Shock 1 1
Easy Bruising 1 1
Alteration In Body Temperature 1 1
Foreign Body Sensation in Eye 1 1
Fluid Discharge 1 1
Abnormal Blood Gases 1 1
Low Blood Pressure/ Hypotension 1 1
Jaundice 1 1
Radiation Underdose 1 1
Not Applicable 1 1
Inflammation 1 1
Pseudoaneurysm 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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