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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 3
AVIA VASCULAR
  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
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
  1.  K220799  K-SHIELD Zen
KURIN, INC
  SUBSTANTIALLY EQUIVALENT 2
MAGNOLIA MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MAGNOLIA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NSP TECH PTE LTD
  SUBSTANTIALLY EQUIVALENT 3
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SB-KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K220799  K-SHIELD Zen
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 3
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
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 3374 3374

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4560 4560
Short Fill 4459 4459
Incorrect, Inadequate or Imprecise Result or Readings 4312 4312
Device Contamination with Chemical or Other Material 3690 3690
Volume Accuracy Problem 2690 2690
Incorrect Or Inadequate Test Results 2357 2357
Fluid/Blood Leak 1398 1398
Device Markings/Labelling Problem 1288 1288
Overfill 1084 1084
Material Deformation 1051 1051
Coagulation in Device or Device Ingredient 1041 1041
Break 750 750
Product Quality Problem 473 473
Component Missing 421 421
Device Ingredient or Reagent Problem 399 399
Difficult or Delayed Activation 396 396
Difficult to Insert 279 279
Detachment Of Device Component 249 249
Device Operates Differently Than Expected 239 239
Separation Problem 232 232
Delivered as Unsterile Product 208 208
Material Protrusion/Extrusion 199 199
Crack 174 174
Complete Blockage 118 118
Missing Information 118 118
Incorrect Measurement 113 113
Improper or Incorrect Procedure or Method 94 94
Filling Problem 89 89
Packaging Problem 87 87
Defective Component 72 72
Material Separation 71 71
Retraction Problem 71 71
Material Discolored 71 71
No Device Output 70 70
Detachment of Device or Device Component 70 70
Hole In Material 65 65
Device Contamination with Body Fluid 64 64
Loose or Intermittent Connection 53 53
Premature Separation 48 48
Defective Device 47 47
Physical Resistance/Sticking 46 46
Device Damaged Prior to Use 45 45
Fracture 43 43
Clumping in Device or Device Ingredient 43 43
Material Twisted/Bent 36 36
Material Integrity Problem 33 33
Deformation Due to Compressive Stress 31 31
Separation Failure 29 29
Device Dislodged or Dislocated 28 28
Adverse Event Without Identified Device or Use Problem 28 28
Fail-Safe Problem 26 26
Structural Problem 26 26
Material Puncture/Hole 26 26
Contamination 25 25
Disconnection 25 25
Inaccurate Information 24 24
High Test Results 22 22
Fungus in Device Environment 21 21
Mechanical Problem 21 21
Inability to Auto-Fill 19 19
Component Misassembled 19 19
Device Damaged by Another Device 19 19
Illegible Information 17 17
Therapeutic or Diagnostic Output Failure 16 16
Component Falling 16 16
Unsealed Device Packaging 16 16
Nonstandard Device 15 15
Obstruction of Flow 15 15
Use of Device Problem 15 15
Output Problem 15 15
Manufacturing, Packaging or Shipping Problem 15 15
Cut In Material 14 14
Suction Problem 14 14
Shipping Damage or Problem 14 14
Component Incompatible 14 14
Expiration Date Error 13 13
Insufficient Information 13 13
Appropriate Term/Code Not Available 13 13
Material Split, Cut or Torn 12 12
Air Leak 12 12
Decrease in Suction 11 11
Entrapment of Device 11 11
Microbial Contamination of Device 11 11
Insufficient Flow or Under Infusion 11 11
Unclear Information 11 11
Connection Problem 11 11
Contamination of Device Ingredient or Reagent 11 11
Improper Chemical Reaction 10 10
Protective Measures Problem 10 10
Non Reproducible Results 10 10
Sticking 10 10
Fail-Safe Design Failure 10 10
Bent 10 10
Burst Container or Vessel 9 9
Occlusion Within Device 9 9
Device Slipped 9 9
Device Inoperable 9 9
Split 9 9
Improper Flow or Infusion 9 9
Contamination /Decontamination Problem 8 8

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 6508 6508
No Consequences Or Impact To Patient 3716 3716
No Information 1345 1345
No Patient Involvement 934 934
Needle Stick/Puncture 267 267
Exposure to Body Fluids 144 144
Insufficient Information 128 128
No Code Available 82 82
Test Result 72 72
Hemolysis 59 59
Blood Loss 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Injury 19 19
Pain 19 19
Hemorrhage/Bleeding 15 15
Foreign Body In Patient 11 11
Laceration(s) 9 9
Bruise/Contusion 8 8
Thrombus 8 8
Hematoma 6 6
Device Embedded In Tissue or Plaque 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
Cardiogenic Shock 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
Muscle/Tendon Damage 1 1
Skin Inflammation/ Irritation 1 1
Easy Bruising 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 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 Becton Dickinson & Company II Nov-09-2017
15 Becton Dickinson & Company II Apr-06-2017
16 Becton Dickinson & Company II Feb-10-2017
17 C.A. Greiner & Sohne Gesellschaftmbh II May-26-2020
18 Centurion Medical Products Corporation II Jul-09-2020
19 Greiner Bio-One North America, Inc. II Jan-18-2022
20 Greiner Bio-One North America, Inc. II Sep-24-2021
21 Greiner Bio-One North America, Inc. II Sep-29-2020
22 Greiner Bio-One North America, Inc. II Jan-17-2020
23 Magnolia Medical Technologies, Inc. II Dec-01-2021
24 Magnolia Medical Technologies, Inc. II Aug-31-2021
25 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
26 Radiometer Medical ApS II May-19-2022
27 Radiometer Medical ApS II May-26-2021
28 Smiths Medical ASD Inc. II Feb-15-2019
29 Smiths Medical ASD Inc. III Sep-19-2018
30 Smiths Medical ASD, Inc. II Apr-15-2020
31 Velano Vascular II Jan-25-2022
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