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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
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 3600 3600

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4485 4485
Incorrect, Inadequate or Imprecise Resultor Readings 3994 3994
Short Fill 3926 3926
Device Contamination with Chemical or Other Material 3359 3359
Volume Accuracy Problem 2612 2612
Incorrect Or Inadequate Test Results 2357 2357
Device Markings/Labelling Problem 1257 1257
Fluid Leak 1171 1171
Overfill 1030 1030
Material Deformation 905 905
Coagulation in Device or Device Ingredient 892 892
Break 564 564
Product Quality Problem 406 406
Difficult or Delayed Activation 380 380
Component Missing 379 379
Detachment Of Device Component 249 249
Device Operates Differently Than Expected 239 239
Difficult to Insert 227 227
Material Protrusion/Extrusion 197 197
Delivered as Unsterile Product 187 187
Crack 145 145
Incorrect Measurement 110 110
Complete Blockage 105 105
Packaging Problem 78 78
Improper or Incorrect Procedure or Method 72 72
No Device Output 69 69
Hole In Material 65 65
Device Contamination with Body Fluid 57 57
Retraction Problem 52 52
Detachment of Device or Device Component 51 51
Missing Information 50 50
Material Separation 49 49
Loose or Intermittent Connection 48 48
Device Damaged Prior to Use 44 44
Filling Problem 43 43
Device Ingredient or Reagent Problem 43 43
Defective Component 35 35
Defective Device 30 30
Material Discolored 29 29
Deformation Due to Compressive Stress 27 27
Material Integrity Problem 27 27
Adverse Event Without Identified Device or Use Problem 26 26
Device Dislodged or Dislocated 25 25
Structural Problem 24 24
Fail-Safe Problem 23 23
High Test Results 21 21
Fungus in Device Environment 16 16
Contamination 16 16
Component Falling 16 16
Device Damaged by Another Device 16 16
Therapeutic or Diagnostic Output Failure 15 15
Disconnection 15 15
Mechanical Problem 14 14
Cut In Material 14 14
Nonstandard Device 13 13
Unsealed Device Packaging 13 13
Component Incompatible 13 13
Insufficient Information 13 13
Illegible Information 13 13
Inaccurate Information 13 13
Appropriate Term/Code Not Available 12 12
Air Leak 12 12
Fracture 12 12
Suction Problem 12 12
Shipping Damage or Problem 11 11
Decrease in Suction 11 11
Entrapment of Device 10 10
Fail-Safe Design Failure 10 10
Bent 10 10
Sticking 10 10
Unclear Information 10 10
Non Reproducible Results 10 10
Improper Chemical Reaction 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Separation Failure 9 9
Protective Measures Problem 9 9
Device Slipped 9 9
Microbial Contamination of Device 9 9
Device Inoperable 9 9
Obstruction of Flow 9 9
Connection Problem 9 9
Contamination of Device Ingredient or Reagent 9 9
Split 9 9
Burst Container or Vessel 9 9
Occlusion Within Device 9 9
Contamination /Decontamination Problem 8 8
Output Problem 8 8
Device Packaging Compromised 8 8
Difficult to Open or Close 7 7
Torn Material 7 7
Expiration Date Error 7 7
Device Expiration Issue 7 7
Misassembled 7 7
Low Test Results 6 6
High Readings 6 6
Device Handling Problem 6 6
Scratched Material 5 5
Positioning Problem 5 5
Fail-Safe Did Not Operate 5 5
Material Twisted/Bent 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15833 15834
No Consequences Or Impact To Patient 3716 3716
No Clinical Signs, Symptoms or Conditions 3215 3215
No Information 1345 1345
No Patient Involvement 934 934
Needle Stick/Puncture 221 221
Exposure to Body Fluids 138 138
Insufficient Information 105 105
No Code Available 82 82
Test Result 72 72
Blood Loss 56 56
Hemolysis 56 56
Injury 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Pain 17 17
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
Vomiting 2 2
Convulsion, Clonic 2 2
Tissue Damage 2 2
Respiratory Distress 2 2
Abrasion 2 2
Erythema 2 2
Extravasation 2 2
Reinfusion 2 2
Alteration In Body Temperature 2 2
Patient Problem/Medical Problem 2 2
Unspecified Mental, Emotional or Behavioural Problem 1 1
Thrombosis/Thrombus 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
Fever 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

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