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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 1
BECTON, DICKINSON & COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 1
GREINER BIO-ONE NA INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KURIN, INC
  SUBSTANTIALLY EQUIVALENT 2
MAGNOLIA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NSP TECH PTE LTD
  SUBSTANTIALLY EQUIVALENT 3
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 3
ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2038 2038
2018 9731 9731
2019 6469 6469
2020 3774 3774
2021 3610 3610
2022 1283 1283

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4504 4504
Incorrect, Inadequate or Imprecise Resultor Readings 4183 4183
Short Fill 4119 4119
Device Contamination with Chemical or Other Material 3506 3506
Volume Accuracy Problem 2649 2649
Incorrect Or Inadequate Test Results 2357 2357
Fluid Leak 1311 1311
Device Markings/Labelling Problem 1263 1263
Overfill 1052 1052
Material Deformation 965 965
Coagulation in Device or Device Ingredient 958 958
Break 610 610
Product Quality Problem 426 426
Component Missing 396 396
Difficult or Delayed Activation 387 387
Detachment Of Device Component 249 249
Difficult to Insert 246 246
Device Operates Differently Than Expected 239 239
Material Protrusion/Extrusion 199 199
Delivered as Unsterile Product 195 195
Crack 154 154
Device Ingredient or Reagent Problem 120 120
Complete Blockage 112 112
Incorrect Measurement 111 111
Improper or Incorrect Procedure or Method 92 92
Packaging Problem 83 83
Missing Information 73 73
No Device Output 69 69
Hole In Material 65 65
Device Contamination with Body Fluid 63 63
Retraction Problem 61 61
Material Separation 60 60
Filling Problem 58 58
Detachment of Device or Device Component 58 58
Loose or Intermittent Connection 50 50
Material Discolored 47 47
Device Damaged Prior to Use 45 45
Separation Problem 40 40
Defective Component 39 39
Defective Device 34 34
Material Twisted/Bent 30 30
Material Integrity Problem 30 30
Deformation Due to Compressive Stress 29 29
Adverse Event Without Identified Device or Use Problem 28 28
Fracture 27 27
Structural Problem 25 25
Device Dislodged or Dislocated 25 25
Fail-Safe Problem 24 24
Disconnection 23 23
Fungus in Device Environment 21 21
High Test Results 21 21
Material Puncture/Hole 19 19
Device Damaged by Another Device 19 19
Contamination 18 18
Mechanical Problem 17 17
Component Falling 16 16
Therapeutic or Diagnostic Output Failure 16 16
Inaccurate Information 15 15
Illegible Information 14 14
Component Incompatible 14 14
Unsealed Device Packaging 14 14
Nonstandard Device 14 14
Cut In Material 14 14
Insufficient Information 13 13
Appropriate Term/Code Not Available 12 12
Physical Resistance/Sticking 12 12
Suction Problem 12 12
Air Leak 12 12
Decrease in Suction 11 11
Shipping Damage or Problem 11 11
Expiration Date Error 11 11
Obstruction of Flow 11 11
Unclear Information 11 11
Non Reproducible Results 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Improper Chemical Reaction 10 10
Connection Problem 10 10
Separation Failure 10 10
Sticking 10 10
Entrapment of Device 10 10
Fail-Safe Design Failure 10 10
Bent 10 10
Burst Container or Vessel 9 9
Clumping in Device or Device Ingredient 9 9
Occlusion Within Device 9 9
Device Slipped 9 9
Device Inoperable 9 9
Split 9 9
Microbial Contamination of Device 9 9
Contamination of Device Ingredient or Reagent 9 9
Protective Measures Problem 9 9
Output Problem 8 8
Contamination /Decontamination Problem 8 8
Device Packaging Compromised 8 8
Misassembled 8 8
Device Expiration Issue 7 7
Use of Device Problem 7 7
Difficult to Open or Close 7 7
Torn Material 7 7
Device Handling Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15833 15834
No Clinical Signs, Symptoms or Conditions 4476 4476
No Consequences Or Impact To Patient 3716 3716
No Information 1345 1345
No Patient Involvement 934 934
Needle Stick/Puncture 235 235
Exposure to Body Fluids 138 138
Insufficient Information 116 116
No Code Available 82 82
Test Result 72 72
Hemolysis 57 57
Blood Loss 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Injury 19 19
Pain 18 18
Hemorrhage/Bleeding 15 15
Laceration(s) 9 9
Bruise/Contusion 8 8
Thrombus 8 8
Hematoma 6 6
Device Embedded In Tissue or Plaque 5 5
Foreign Body In Patient 5 5
Chemical Exposure 4 4
Hypersensitivity/Allergic reaction 4 4
Venipuncture 3 3
Swelling/ Edema 3 3
Patient Problem/Medical Problem 2 2
Reinfusion 2 2
Alteration In Body Temperature 2 2
Vomiting 2 2
Convulsion, Clonic 2 2
Tissue Damage 2 2
Respiratory Distress 2 2
Abrasion 2 2
Erythema 2 2
Extravasation 2 2
Fever 1 1
Foreign Body Sensation in Eye 1 1
Headache 1 1
Syncope 1 1
Death 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Infection 1 1
Itching Sensation 1 1
Muscle Spasm(s) 1 1
Muscular Rigidity 1 1
Nausea 1 1
Nerve Damage 1 1
Shock 1 1
Swelling 1 1
Hyperglycemia 1 1
Peeling 1 1
Complaint, Ill-Defined 1 1
Rupture 1 1
Burning Sensation 1 1
Radiation Underdose 1 1
Twitching 1 1
Jaundice 1 1
Fluid Discharge 1 1
Pseudoaneurysm 1 1
Not Applicable 1 1
Reaction 1 1
Collapse 1 1
Depression 1 1
Sleep Dysfunction 1 1
Lethargy 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Thrombosis/Thrombus 1 1
Injection Site Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advance Dx, Inc. II Aug-10-2021
2 Becton Dickinson & Company III Feb-23-2022
3 Becton Dickinson & Company II Oct-07-2019
4 Becton Dickinson & Company II Aug-21-2019
5 Becton Dickinson & Company II Jul-12-2019
6 Becton Dickinson & Company II Apr-10-2019
7 Becton Dickinson & Company II Jun-20-2018
8 Becton Dickinson & Company II Jun-01-2018
9 Becton Dickinson & Company II Apr-26-2018
10 Becton Dickinson & Company II Mar-26-2018
11 Becton Dickinson & Company I Mar-22-2018
12 Becton Dickinson & Company II Mar-12-2018
13 Becton Dickinson & Company II Nov-09-2017
14 Becton Dickinson & Company II Apr-06-2017
15 Becton Dickinson & Company II Feb-10-2017
16 C.A. Greiner & Sohne Gesellschaftmbh II May-26-2020
17 Centurion Medical Products Corporation II Jul-09-2020
18 Greiner Bio-One North America, Inc. II Jan-18-2022
19 Greiner Bio-One North America, Inc. II Sep-24-2021
20 Greiner Bio-One North America, Inc. II Sep-29-2020
21 Greiner Bio-One North America, Inc. II Jan-17-2020
22 Magnolia Medical Technologies, Inc. II Dec-01-2021
23 Magnolia Medical Technologies, Inc. II Aug-31-2021
24 Radiometer Medical ApS II May-19-2022
25 Radiometer Medical ApS II May-26-2021
26 Smiths Medical ASD Inc. II Feb-15-2019
27 Smiths Medical ASD Inc. III Sep-19-2018
28 Smiths Medical ASD, Inc. II Apr-15-2020
29 Velano Vascular II Jan-25-2022
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