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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 2
BECTON, DICKINSON & COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
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
JIANGSU CAINA MEDICAL CO., LTD.
  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
KURIN, INC,
  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
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU MEDLINE INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 9731 9731
2019 6469 6469
2020 3774 3774
2021 3610 3610
2022 3375 3375
2023 2911 2911

Device Problems MDRs with this Device Problem Events in those MDRs
Short Fill 5001 5001
Incorrect, Inadequate or Imprecise Result or Readings 4584 4584
Leak/Splash 4403 4403
Device Contamination with Chemical or Other Material 3853 3853
Volume Accuracy Problem 2701 2701
Incorrect Or Inadequate Test Results 2350 2350
Device Markings/Labelling Problem 1318 1318
Overfill 1179 1179
Fluid/Blood Leak 1158 1158
Coagulation in Device or Device Ingredient 1155 1155
Material Deformation 1110 1110
Device Ingredient or Reagent Problem 834 834
Break 603 603
Product Quality Problem 515 515
Separation Problem 467 467
Difficult or Delayed Activation 424 424
Difficult to Insert 334 334
Component Missing 322 322
Delivered as Unsterile Product 217 217
Material Protrusion/Extrusion 199 199
Missing Information 162 162
Complete Blockage 127 127
Incorrect Measurement 112 112
Filling Problem 101 101
Crack 100 100
Improper or Incorrect Procedure or Method 95 95
Packaging Problem 86 86
Physical Resistance/Sticking 78 78
Material Discolored 77 77
No Device Output 71 71
Material Separation 65 65
Detachment of Device or Device Component 65 65
Clumping in Device or Device Ingredient 64 64
Fracture 62 62
Device Contamination with Body Fluid 62 62
Retraction Problem 59 59
Defective Component 58 58
Premature Separation 58 58
Material Twisted/Bent 47 47
Difficult to Remove 47 47
Device Damaged Prior to Use 41 41
Defective Device 40 40
Material Puncture/Hole 40 40
Detachment Of Device Component 38 38
Device Operates Differently Than Expected 38 38
Separation Failure 38 38
Deformation Due to Compressive Stress 34 34
Inaccurate Information 34 34
Contamination 29 29
Output Problem 26 26
Adverse Event Without Identified Device or Use Problem 25 25
Component Misassembled 23 23
Illegible Information 21 21
Inability to Auto-Fill 21 21
High Test Results 21 21
Fungus in Device Environment 20 20
Obstruction of Flow 19 19
Device Damaged by Another Device 19 19
Structural Problem 18 18
Component Incompatible 17 17
Nonstandard Device 16 16
Mechanical Problem 16 16
Use of Device Problem 16 16
Air/Gas in Device 16 16
Therapeutic or Diagnostic Output Failure 16 16
Disconnection 15 15
Shipping Damage or Problem 14 14
Microbial Contamination of Device 14 14
Material Integrity Problem 14 14
Material Split, Cut or Torn 13 13
Unclear Information 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Contamination of Device Ingredient or Reagent 12 12
Contamination /Decontamination Problem 11 11
Loose or Intermittent Connection 11 11
Fail-Safe Problem 11 11
Device Dislodged or Dislocated 10 10
Improper Chemical Reaction 10 10
Fail-Safe Did Not Operate 10 10
Non Reproducible Results 10 10
Expiration Date Error 10 10
Failure to Obtain Sample 9 9
Suction Problem 9 9
Insufficient Flow or Under Infusion 9 9
Positioning Failure 9 9
False Positive Result 9 9
Improper Flow or Infusion 9 9
Appropriate Term/Code Not Available 8 8
Unsealed Device Packaging 8 8
High Readings 8 8
Blocked Connection 7 7
Misconnection 7 7
Device Handling Problem 7 7
Insufficient Information 7 7
Difficult or Delayed Separation 7 7
Protective Measures Problem 7 7
Unintended Movement 6 6
Difficult to Advance 6 6
Ejection Problem 6 6
Hole In Material 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14374 14375
No Clinical Signs, Symptoms or Conditions 9336 9336
No Consequences Or Impact To Patient 3267 3267
No Information 1333 1333
No Patient Involvement 917 917
Needle Stick/Puncture 272 272
Insufficient Information 157 157
Exposure to Body Fluids 130 130
No Code Available 80 80
Test Result 70 70
Hemolysis 59 59
Blood Loss 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Pain 21 21
Injury 15 15
Hemorrhage/Bleeding 13 13
Foreign Body In Patient 10 10
Bruise/Contusion 8 8
Thrombus 8 8
Laceration(s) 7 7
Extravasation 6 6
Hematoma 5 5
Device Embedded In Tissue or Plaque 5 5
Chemical Exposure 4 4
Skin Inflammation/ Irritation 4 4
Swelling/ Edema 4 4
Discomfort 4 4
Hypersensitivity/Allergic reaction 3 3
Erythema 2 2
Reinfusion 2 2
Convulsion, Clonic 2 2
Tissue Damage 2 2
Local Reaction 2 2
Respiratory Distress 2 2
Nerve Damage 2 2
Patient Problem/Medical Problem 2 2
Alteration In Body Temperature 2 2
Fluid Discharge 1 1
Pseudoaneurysm 1 1
Not Applicable 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Thrombosis/Thrombus 1 1
Muscle/Tendon Damage 1 1
Easy Bruising 1 1
Injection Site Reaction 1 1
Swelling 1 1
Peeling 1 1
Vomiting 1 1
Burning Sensation 1 1
Radiation Underdose 1 1
Jaundice 1 1
Cardiogenic Shock 1 1
Rupture 1 1
Collapse 1 1
Complaint, Ill-Defined 1 1
Foreign Body Sensation in Eye 1 1
Headache 1 1
Death 1 1
Abnormal Blood Gases 1 1
Syncope 1 1
Abrasion 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Infection 1 1
Inflammation 1 1
Itching Sensation 1 1
Muscle Spasm(s) 1 1
Nausea 1 1
Hyperglycemia 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 Becton Dickinson & Company II Jun-20-2018
9 Becton Dickinson & Company II Jun-01-2018
10 Becton Dickinson & Company II Apr-26-2018
11 Becton Dickinson & Company II Mar-26-2018
12 Becton Dickinson & Company I Mar-22-2018
13 Becton Dickinson & Company II Mar-12-2018
14 C.A. Greiner & Sohne Gesellschaftmbh II May-26-2020
15 Centurion Medical Products Corporation II Jul-09-2020
16 Greiner Bio-One North America, Inc. II May-12-2023
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 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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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