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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device tubes, vials, systems, serum separators, blood collection
Regulation Description Blood specimen collection device.
Product CodeJKA
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
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
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
PATHWAY LLC
  SUBSTANTIALLY EQUIVALENT 1
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VELANO VASCULAR
  SUBSTANTIALLY EQUIVALENT 4
ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 65 65
2017 2038 2038
2018 9731 9731
2019 6469 6469
2020 3774 3774
2021 2586 2586

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4476 4476
Incorrect, Inadequate or Imprecise Resultor Readings 3791 3791
Short Fill 3710 3710
Device Contamination with Chemical or Other Material 3261 3261
Volume Accuracy Problem 2409 2409
Incorrect Or Inadequate Test Results 2359 2359
Device Markings/Labelling Problem 1253 1253
Overfill 1018 1018
Fluid Leak 919 919
Material Deformation 899 899
Coagulation in Device or Device Ingredient 835 835
Break 553 553
Product Quality Problem 384 384
Difficult or Delayed Activation 372 372
Component Missing 370 370
Detachment Of Device Component 259 259
Device Operates Differently Than Expected 245 245
Difficult to Insert 210 210
Material Protrusion/Extrusion 196 196
Delivered as Unsterile Product 181 181
Crack 148 148
Incorrect Measurement 109 109
Complete Blockage 102 102
Packaging Problem 76 76
Improper or Incorrect Procedure or Method 70 70
No Device Output 69 69
Hole In Material 65 65
Retraction Problem 62 62
Device Contamination with Body Fluid 56 56
Loose or Intermittent Connection 50 50
Material Separation 50 50
Device Damaged Prior to Use 43 43
Filling Problem 40 40
Detachment of Device or Device Component 39 39
Defective Component 34 34
Missing Information 32 32
Defective Device 32 32
Material Integrity Problem 27 27
Adverse Event Without Identified Device or Use Problem 26 26
Device Ingredient or Reagent Problem 26 26
Device Dislodged or Dislocated 26 26
Fail-Safe Problem 25 25
Material Discolored 24 24
High Test Results 22 22
Structural Problem 22 22
Deformation Due to Compressive Stress 21 21
Fungus in Device Environment 16 16
Component Falling 16 16
Disconnection 15 15
Device Damaged by Another Device 14 14
Insufficient Information 14 14
Therapeutic or Diagnostic Output Failure 14 14
Cut In Material 14 14
Nonstandard Device 14 14
Fracture 14 14
Mechanical Problem 14 14
Unsealed Device Packaging 13 13
Component Incompatible 13 13
Illegible Information 13 13
Fail-Safe Design Failure 13 13
Appropriate Term/Code Not Available 12 12
Air Leak 12 12
Suction Problem 12 12
Shipping Damage or Problem 11 11
Decrease in Suction 11 11
Sticking 11 11
Contamination 10 10
Entrapment of Device 10 10
Improper Chemical Reaction 10 10
Connection Problem 10 10
Contamination of Device Ingredient or Reagent 10 10
Non Reproducible Results 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Burst Container or Vessel 10 10
Bent 10 10
Protective Measures Problem 10 10
Inaccurate Information 10 10
Device Slipped 9 9
Split 9 9
Device Inoperable 9 9
Occlusion Within Device 9 9
Contamination /Decontamination Problem 8 8
Separation Failure 8 8
Obstruction of Flow 8 8
Unclear Information 8 8
Device Packaging Compromised 8 8
Difficult to Open or Close 7 7
Expiration Date Error 7 7
Torn Material 7 7
Use of Device Problem 7 7
Device Expiration Issue 7 7
Misassembled 7 7
Low Test Results 6 6
High Readings 6 6
Device Handling Problem 6 6
Material Twisted/Bent 5 5
False Positive Result 5 5
Positioning Failure 5 5
Material Fragmentation 5 5
Microbial Contamination of Device 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15844 15845
No Consequences Or Impact To Patient 3727 3727
No Clinical Signs, Symptoms or Conditions 2220 2220
No Information 1350 1350
No Patient Involvement 936 936
Needle Stick/Puncture 240 240
Exposure to Body Fluids 148 148
Insufficient Information 90 90
No Code Available 83 83
Test Result 72 72
Hemolysis 56 56
Blood Loss 56 56
Injury 23 23
Pain 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Hemorrhage/Bleeding 15 15
Laceration(s) 10 10
Bruise/Contusion 8 8
Thrombus 8 8
Hematoma 6 6
Foreign Body In Patient 6 6
Device Embedded In Tissue or Plaque 6 6
Chemical Exposure 4 4
Hypersensitivity/Allergic reaction 4 4
Venipuncture 3 3
Vomiting 2 2
Nerve Damage 2 2
Patient Problem/Medical Problem 2 2
Alteration In Body Temperature 2 2
Respiratory Distress 2 2
Convulsion, Clonic 2 2
Reinfusion 2 2
Tissue Damage 2 2
Abrasion 2 2
Erythema 2 2
Extravasation 2 2
Therapeutic Effects, Unexpected 2 2
Fever 1 1
Muscle Spasm(s) 1 1
Peeling 1 1
Swelling 1 1
Radiation Underdose 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Rupture 1 1
Numbness 1 1
Collapse 1 1
Sleep Dysfunction 1 1
Lethargy 1 1
Fluid Discharge 1 1
Not Applicable 1 1
Reaction 1 1
Depression 1 1
Complaint, Ill-Defined 1 1
Shock 1 1
Pseudoaneurysm 1 1
Syncope 1 1
Muscular Rigidity 1 1
Nausea 1 1
Burning Sensation 1 1
Tingling 1 1
Twitching 1 1
Jaundice 1 1
Death 1 1
Headache 1 1
Hyperglycemia 1 1
Unspecified Infection 1 1
Itching Sensation 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 Becton Dickinson & Company II Dec-12-2016
16 Becton Dickinson & Company II Sep-01-2016
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 Sep-29-2020
20 Greiner Bio-One North America, Inc. II Jan-17-2020
21 Greiner Bio-One North America, Inc. II Jun-07-2016
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
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