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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
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 5
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 NA INC.
  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
KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KURIN, INC
  SUBSTANTIALLY EQUIVALENT 2
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 3
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 2
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU MEDLINE INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6469 6469
2020 3774 3774
2021 3610 3610
2022 3375 3375
2023 4399 4399
2024 3119 3119

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4733 4733
Short Fill 4551 4551
Leak/Splash 3207 3207
Device Contamination with Chemical or Other Material 2998 2998
Volume Accuracy Problem 2011 2011
Device Ingredient or Reagent Problem 1284 1284
Fluid/Blood Leak 1159 1159
Device Markings/Labelling Problem 1073 1073
Coagulation in Device or Device Ingredient 884 884
Overfill 850 850
Material Deformation 812 812
Separation Problem 591 591
Break 562 562
Product Quality Problem 482 482
Difficult or Delayed Activation 390 390
Difficult to Insert 340 340
Component Missing 290 290
Missing Information 175 175
Crack 137 137
Delivered as Unsterile Product 121 121
Material Protrusion/Extrusion 119 119
Filling Problem 112 112
Material Discolored 106 106
Improper or Incorrect Procedure or Method 106 106
Premature Separation 105 105
Complete Blockage 90 90
Physical Resistance/Sticking 89 89
Packaging Problem 87 87
Detachment of Device or Device Component 84 84
Material Separation 80 80
Defective Component 79 79
Clumping in Device or Device Ingredient 66 66
Fracture 63 63
Failure to Obtain Sample 60 60
Device Contamination with Body Fluid 60 60
Difficult to Remove 59 59
Incorrect Measurement 55 55
Material Twisted/Bent 50 50
Contamination 50 50
Separation Failure 49 49
Retraction Problem 49 49
Output Problem 42 42
Material Puncture/Hole 42 42
Inaccurate Information 37 37
Deformation Due to Compressive Stress 35 35
Defective Device 35 35
Adverse Event Without Identified Device or Use Problem 34 34
No Device Output 28 28
Device Damaged Prior to Use 26 26
Illegible Information 25 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13848 13848
No Known Impact Or Consequence To Patient 7289 7289
No Consequences Or Impact To Patient 1863 1863
No Patient Involvement 882 882
No Information 277 277
Needle Stick/Puncture 262 262
Insufficient Information 184 184
Exposure to Body Fluids 104 104
No Code Available 68 68
Test Result 67 67
Hemolysis 36 36
Blood Loss 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Pain 19 19
Discomfort 11 11
Hemorrhage/Bleeding 10 10
Foreign Body In Patient 8 8
Injury 6 6
Extravasation 6 6
Hematoma 6 6
Swelling/ Edema 5 5
Skin Inflammation/ Irritation 4 4
Thrombus 4 4
Bruise/Contusion 4 4
Laceration(s) 4 4
Chemical Exposure 3 3
Hypersensitivity/Allergic reaction 3 3
Tissue Damage 2 2
Abrasion 2 2
Local Reaction 2 2
Reinfusion 2 2
Convulsion, Clonic 2 2
Erythema 2 2
Nerve Damage 2 2
Device Embedded In Tissue or Plaque 2 2
Pseudoaneurysm 1 1
Perforation of Vessels 1 1
Muscle/Tendon Damage 1 1
Headache 1 1
Fluid Discharge 1 1
Radiation Underdose 1 1
Peeling 1 1
Low Blood Pressure/ Hypotension 1 1
Hyperglycemia 1 1
Cardiogenic Shock 1 1
Jaundice 1 1
Vomiting 1 1
Swelling 1 1
Muscle Spasm(s) 1 1
Thrombosis/Thrombus 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 Becton Dickinson & Company II Oct-07-2019
5 Becton Dickinson & Company II Aug-21-2019
6 Becton Dickinson & Company II Jul-12-2019
7 Becton Dickinson & Company II Apr-10-2019
8 C.A. Greiner & Sohne Gesellschaftmbh II May-26-2020
9 Centurion Medical Products Corporation II Jul-09-2020
10 Greiner Bio-One North America, Inc. II Jul-17-2024
11 Greiner Bio-One North America, Inc. II Jan-16-2024
12 Greiner Bio-One North America, Inc. II May-12-2023
13 Greiner Bio-One North America, Inc. II Jan-18-2022
14 Greiner Bio-One North America, Inc. II Sep-24-2021
15 Greiner Bio-One North America, Inc. II Sep-29-2020
16 Greiner Bio-One North America, Inc. II Jan-17-2020
17 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
18 Magnolia Medical Technologies, Inc. II Dec-01-2021
19 Magnolia Medical Technologies, Inc. II Aug-31-2021
20 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
21 Radiometer Medical ApS II May-19-2022
22 Radiometer Medical ApS II May-26-2021
23 Smiths Medical ASD Inc. II Oct-20-2023
24 Smiths Medical ASD Inc. II Feb-15-2019
25 Smiths Medical ASD, Inc. II Apr-15-2020
26 Velano Vascular II Jan-25-2022
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