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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
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 1239 1239

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4353 4353
Short Fill 4300 4300
Leak/Splash 2899 2899
Device Contamination with Chemical or Other Material 2763 2763
Volume Accuracy Problem 1980 1980
Device Ingredient or Reagent Problem 1190 1190
Fluid/Blood Leak 1125 1125
Device Markings/Labelling Problem 1012 1012
Coagulation in Device or Device Ingredient 816 816
Overfill 787 787
Material Deformation 756 756
Separation Problem 563 563
Break 527 527
Product Quality Problem 446 446
Difficult or Delayed Activation 378 378
Difficult to Insert 295 295
Component Missing 262 262
Missing Information 172 172
Delivered as Unsterile Product 121 121
Crack 120 120
Material Protrusion/Extrusion 109 109
Filling Problem 108 108
Improper or Incorrect Procedure or Method 100 100
Material Discolored 93 93
Premature Separation 88 88
Physical Resistance/Sticking 88 88
Complete Blockage 83 83
Packaging Problem 79 79
Material Separation 74 74
Defective Component 73 73
Detachment of Device or Device Component 73 73
Clumping in Device or Device Ingredient 65 65
Fracture 58 58
Difficult to Remove 58 58
Incorrect Measurement 55 55
Device Contamination with Body Fluid 55 55
Retraction Problem 49 49
Contamination 48 48
Material Twisted/Bent 47 47
Separation Failure 45 45
Output Problem 42 42
Material Puncture/Hole 38 38
Inaccurate Information 37 37
Defective Device 35 35
Deformation Due to Compressive Stress 35 35
Adverse Event Without Identified Device or Use Problem 32 32
No Device Output 28 28
Failure to Obtain Sample 24 24
Device Damaged Prior to Use 24 24
Component Misassembled 23 23
Illegible Information 22 22
Obstruction of Flow 21 21
Inability to Auto-Fill 21 21
False Negative Result 20 20
Air/Gas in Device 20 20
Fungus in Device Environment 18 18
Use of Device Problem 17 17
Therapeutic or Diagnostic Output Failure 16 16
Disconnection 15 15
Mechanical Problem 15 15
Nonstandard Device 14 14
Shipping Damage or Problem 14 14
Contamination of Device Ingredient or Reagent 14 14
Device Damaged by Another Device 14 14
Material Split, Cut or Torn 13 13
Unclear Information 12 12
Contamination /Decontamination Problem 12 12
Microbial Contamination of Device 12 12
Component Incompatible 12 12
False Positive Result 11 11
Material Integrity Problem 11 11
Non Reproducible Results 11 11
Fail-Safe Did Not Operate 10 10
Difficult or Delayed Separation 10 10
Expiration Date Error 10 10
High Test Results 9 9
Insufficient Flow or Under Infusion 9 9
Improper Flow or Infusion 9 9
Fail-Safe Problem 9 9
Positioning Failure 9 9
Loose or Intermittent Connection 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Unsealed Device Packaging 8 8
Difficult to Advance 8 8
Blocked Connection 8 8
Improper Chemical Reaction 8 8
Suction Problem 8 8
High Readings 7 7
Device Dislodged or Dislocated 7 7
Misconnection 7 7
Structural Problem 6 6
Unintended Movement 6 6
Protective Measures Problem 6 6
Ejection Problem 6 6
Patient Device Interaction Problem 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 5 5
Device Handling Problem 5 5
Unexpected Color 5 5
Low Test Results 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12009 12009
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 238 238
Insufficient Information 179 179
Exposure to Body Fluids 99 99
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 14 14
Discomfort 10 10
Hemorrhage/Bleeding 9 9
Foreign Body In Patient 8 8
Extravasation 6 6
Injury 6 6
Hematoma 5 5
Swelling/ Edema 5 5
Skin Inflammation/ Irritation 4 4
Bruise/Contusion 4 4
Laceration(s) 4 4
Thrombus 4 4
Hypersensitivity/Allergic reaction 3 3
Chemical Exposure 3 3
Device Embedded In Tissue or Plaque 2 2
Erythema 2 2
Abrasion 2 2
Tissue Damage 2 2
Local Reaction 2 2
Nerve Damage 2 2
Reinfusion 2 2
Convulsion, Clonic 2 2
Cardiogenic Shock 1 1
Rupture 1 1
Malaise 1 1
Swelling 1 1
Peeling 1 1
Perforation of Vessels 1 1
Vomiting 1 1
Burning Sensation 1 1
Radiation Underdose 1 1
Jaundice 1 1
Foreign Body Sensation in Eye 1 1
Headache 1 1
Abnormal Blood Gases 1 1
Syncope 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
Not Applicable 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Thrombosis/Thrombus 1 1
Muscle/Tendon Damage 1 1
Pseudoaneurysm 1 1
Patient Problem/Medical Problem 1 1
Alteration In Body Temperature 1 1
Fluid Discharge 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 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 Jan-16-2024
11 Greiner Bio-One North America, Inc. II May-12-2023
12 Greiner Bio-One North America, Inc. II Jan-18-2022
13 Greiner Bio-One North America, Inc. II Sep-24-2021
14 Greiner Bio-One North America, Inc. II Sep-29-2020
15 Greiner Bio-One North America, Inc. II Jan-17-2020
16 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
17 Magnolia Medical Technologies, Inc. II Dec-01-2021
18 Magnolia Medical Technologies, Inc. II Aug-31-2021
19 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
20 Radiometer Medical ApS II May-19-2022
21 Radiometer Medical ApS II May-26-2021
22 Smiths Medical ASD Inc. II Oct-20-2023
23 Smiths Medical ASD Inc. II Feb-15-2019
24 Smiths Medical ASD, Inc. II Apr-15-2020
25 Velano Vascular II Jan-25-2022
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