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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 & CO.
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 5
BECTON DICKINSON AND COMPANY (BD)
  SUBSTANTIALLY EQUIVALENT 1
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 4
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BIO-ANALYSIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTECHNOLOGY INSTITUTE, SL.
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 1
ECLIPSE MEDCORP LLC
  SUBSTANTIALLY EQUIVALENT 1
GREINER BIO-ONE NA INC.
  SUBSTANTIALLY EQUIVALENT 1
GREINER BIO-ONE NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NSP TECH PTE LTD
  SUBSTANTIALLY EQUIVALENT 3
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 1
PATHWAY LLC
  SUBSTANTIALLY EQUIVALENT 1
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SB-KAWASUMI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
THE MONARCH COMPANY
  SUBSTANTIALLY EQUIVALENT 1
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 4
VELANO VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2014 68 68
2015 38 38
2016 65 65
2017 2038 2038
2018 9731 9731
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
Short Fill 5452 5452
Incorrect, Inadequate or Imprecise Result or Readings 5101 5101
Leak/Splash 4928 4928
Device Contamination with Chemical or Other Material 4263 4263
Volume Accuracy Problem 2743 2743
Incorrect Or Inadequate Test Results 2361 2361
Fluid/Blood Leak 1620 1620
Device Markings/Labelling Problem 1445 1445
Overfill 1261 1261
Coagulation in Device or Device Ingredient 1254 1254
Device Ingredient or Reagent Problem 1191 1191
Material Deformation 1191 1191
Break 931 931
Product Quality Problem 567 567
Separation Problem 563 563
Component Missing 486 486
Difficult or Delayed Activation 434 434
Difficult to Insert 386 386
Crack 269 269
Detachment Of Device Component 267 267
Device Operates Differently Than Expected 255 255
Delivered as Unsterile Product 223 223
Material Protrusion/Extrusion 220 220
Missing Information 172 172
Complete Blockage 141 141
Filling Problem 130 130
Material Separation 119 119
Retraction Problem 117 117
Incorrect Measurement 117 117
Improper or Incorrect Procedure or Method 116 116
Packaging Problem 114 114
Material Discolored 109 109
Defective Component 101 101
Detachment of Device or Device Component 94 94
Premature Separation 88 88
Physical Resistance/Sticking 88 88
Device Contamination with Body Fluid 75 75
No Device Output 74 74
Fracture 71 71
Hole In Material 66 66
Clumping in Device or Device Ingredient 66 66
Difficult to Remove 64 64
Loose or Intermittent Connection 56 56
Contamination 54 54
Defective Device 52 52
Separation Failure 51 51
Device Damaged Prior to Use 50 50
Material Twisted/Bent 50 50
Adverse Event Without Identified Device or Use Problem 47 47
Output Problem 42 42
Material Puncture/Hole 40 40
Inaccurate Information 37 37
Material Integrity Problem 36 36
Deformation Due to Compressive Stress 35 35
Device Dislodged or Dislocated 29 29
Fail-Safe Problem 28 28
Mechanical Problem 27 27
Disconnection 26 26
Structural Problem 26 26
High Test Results 25 25
Failure to Obtain Sample 24 24
Obstruction of Flow 23 23
Fungus in Device Environment 23 23
Component Misassembled 23 23
Illegible Information 22 22
Use of Device Problem 22 22
Nonstandard Device 22 22
Component Incompatible 21 21
False Negative Result 21 21
Inability to Auto-Fill 21 21
Air/Gas in Device 20 20
Device Damaged by Another Device 19 19
Manufacturing, Packaging or Shipping Problem 18 18
Contamination of Device Ingredient or Reagent 17 17
Component Falling 17 17
Unsealed Device Packaging 17 17
Fail-Safe Design Failure 17 17
Suction Problem 16 16
Expiration Date Error 16 16
Therapeutic or Diagnostic Output Failure 16 16
Insufficient Information 15 15
Protective Measures Problem 15 15
Cut In Material 14 14
Microbial Contamination of Device 14 14
Shipping Damage or Problem 14 14
Air Leak 14 14
False Positive Result 14 14
Device Slipped 13 13
Appropriate Term/Code Not Available 13 13
Material Split, Cut or Torn 13 13
Contamination /Decontamination Problem 13 13
Connection Problem 13 13
Improper Flow or Infusion 13 13
Unclear Information 12 12
Sticking 12 12
Insufficient Flow or Under Infusion 11 11
Entrapment of Device 11 11
Decrease in Suction 11 11
Non Reproducible Results 11 11
Fail-Safe Did Not Operate 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15875 15876
No Clinical Signs, Symptoms or Conditions 12010 12010
No Consequences Or Impact To Patient 3731 3731
No Information 1364 1364
No Patient Involvement 937 937
Needle Stick/Puncture 373 373
Exposure to Body Fluids 190 190
Insufficient Information 179 179
No Code Available 85 85
Test Result 72 72
Blood Loss 62 62
Hemolysis 59 59
Pain 28 28
Injury 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Hemorrhage/Bleeding 21 21
Foreign Body In Patient 12 12
Laceration(s) 11 11
Discomfort 10 10
Bruise/Contusion 9 9
Thrombus 8 8
Hematoma 6 6
Extravasation 6 6
Hypersensitivity/Allergic reaction 6 6
Venipuncture 6 6
Device Embedded In Tissue or Plaque 6 6
Swelling/ Edema 5 5
Chemical Exposure 4 4
Skin Inflammation/ Irritation 4 4
Abrasion 3 3
Nerve Damage 3 3
Tissue Damage 3 3
Nausea 2 2
Therapeutic Effects, Unexpected 2 2
Local Reaction 2 2
Respiratory Distress 2 2
Itching Sensation 2 2
Erythema 2 2
Patient Problem/Medical Problem 2 2
Alteration In Body Temperature 2 2
Vomiting 2 2
Convulsion, Clonic 2 2
Extubate 2 2
Reinfusion 2 2
Reaction 2 2
Numbness 1 1
Collapse 1 1
Cardiogenic Shock 1 1
Complaint, Ill-Defined 1 1
Burning Sensation 1 1
Radiation Underdose 1 1
Tingling 1 1
Twitching 1 1
Jaundice 1 1
Perforation of Vessels 1 1
Rupture 1 1
Fluid Discharge 1 1
Not Applicable 1 1
Malaise 1 1
Depression 1 1
Pseudoaneurysm 1 1
Palpitations 1 1
Sleep Dysfunction 1 1
Lethargy 1 1
Hyperglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Infection 1 1
Inflammation 1 1
Fever 1 1
Foreign Body Sensation in Eye 1 1
Headache 1 1
Death 1 1
Abnormal Blood Gases 1 1
Syncope 1 1
Muscle Spasm(s) 1 1
Muscular Rigidity 1 1
Occlusion 1 1
Peeling 1 1
Rash 1 1
Increased Sensitivity 1 1
Shock 1 1
Swelling 1 1
Ulceration 1 1
Easy Bruising 1 1
Injection Site Reaction 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Thrombosis/Thrombus 1 1
Muscle/Tendon Damage 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 Becton Dickinson & Company II Dec-12-2016
18 Becton Dickinson & Company II Sep-01-2016
19 Becton Dickinson & Company II Dec-31-2015
20 Becton Dickinson & Company II Dec-21-2015
21 Becton Dickinson & Company III Aug-20-2015
22 Becton Dickinson & Company II Jun-26-2015
23 Becton Dickinson & Company II Aug-07-2013
24 Becton Dickinson & Company III Mar-06-2013
25 Becton Dickinson & Company III Nov-08-2011
26 C.A. Greiner & Sohne Gesellschaftmbh II May-26-2020
27 Capitol Vial Inc II Feb-24-2012
28 Centurion Medical Products Corporation II Jul-09-2020
29 Covidien LP II Mar-07-2011
30 Fresenius Medical Care Holdings, Inc. II Sep-12-2014
31 Greiner Bio-One North America, Inc. II Jan-16-2024
32 Greiner Bio-One North America, Inc. II May-12-2023
33 Greiner Bio-One North America, Inc. II Jan-18-2022
34 Greiner Bio-One North America, Inc. II Sep-24-2021
35 Greiner Bio-One North America, Inc. II Sep-29-2020
36 Greiner Bio-One North America, Inc. II Jan-17-2020
37 Greiner Bio-One North America, Inc. II Jun-07-2016
38 Greiner Bio-One North America, Inc. II Feb-22-2012
39 Greiner Bio-One North America, Inc. II Nov-14-2011
40 Greiner Bio-One North America, Inc. II Dec-16-2010
41 Heritage Labs International LLC II Jan-11-2012
42 Immunetech Inc II Nov-25-2011
43 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
44 Magnolia Medical Technologies, Inc. II Dec-01-2021
45 Magnolia Medical Technologies, Inc. II Aug-31-2021
46 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
47 Perkin Elmer Health Sciences, Inc. II Oct-18-2013
48 Radiometer Medical ApS II May-19-2022
49 Radiometer Medical ApS II May-26-2021
50 Siemens Healthcare Diagnostics Inc II Mar-06-2015
51 Smiths Medical ASD Inc. II Oct-20-2023
52 Smiths Medical ASD Inc. II Feb-15-2019
53 Smiths Medical ASD Inc. III Sep-19-2018
54 Smiths Medical ASD, Inc. II Apr-15-2020
55 Smiths Medical ASD, Inc. III Jan-29-2015
56 Smiths Medical ASD, Inc. II Mar-12-2014
57 Velano Vascular II Jan-25-2022
58 Whatman, Inc. II Sep-07-2010
59 Whatman, Inc. III Mar-05-2010
60 Whatman, Inc. II Sep-30-2009
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