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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device syringe, piston
Regulation Description Piston syringe.
Product CodeFMF
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURO TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
AEA SRL
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
AZUR MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON & COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BIOMET BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BONUS THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 1
CONCEPTOMED AS
  SUBSTANTIALLY EQUIVALENT 2
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
FLAT MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG ANTMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL MEDICAL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERVENE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU KANGYOU MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SUYUN MEDICAL MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFELONG MEDITECH PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LIFENET HEALTH
  SUBSTANTIALLY EQUIVALENT 1
MAZZA HEALTHCARE, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MD3 LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDONE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROMEDICS, INC. (D/B/A NORDSON MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
MILESTONE SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANUM COMPANY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NOVO NORDISK INC.
  SUBSTANTIALLY EQUIVALENT 1
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORBIT BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORBIT BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROCEDURE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KOHOPE MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 2
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO EUROPE N.V.
  SUBSTANTIALLY EQUIVALENT 1
TOP CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA
  SUBSTANTIALLY EQUIVALENT 1
VESCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1857 1857
2018 3951 3951
2019 5862 5863
2020 5330 5330
2021 5798 5801

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6949 6949
Device Contamination with Chemical or Other Material 4078 4079
Break 2009 2009
Volume Accuracy Problem 1250 1250
Device Markings/Labelling Problem 1233 1236
Failure to Deliver 1146 1146
Fluid Leak 762 762
Packaging Problem 570 570
Crack 486 486
Defective Device 482 482
Patient Device Interaction Problem 434 434
Contamination /Decontamination Problem 398 398
Device Operates Differently Than Expected 315 315
Computer Software Problem 279 279
Material Deformation 267 267
Detachment of Device or Device Component 265 265
Delivered as Unsterile Product 259 259
Adverse Event Without Identified Device or Use Problem 240 240
Material Separation 207 207
Defective Component 202 202
Device Damaged Prior to Use 197 197
Component Missing 194 194
Detachment Of Device Component 185 185
Mechanical Problem 173 173
Mechanical Jam 166 166
Physical Resistance/Sticking 165 165
Material Protrusion/Extrusion 151 151
Complete Blockage 149 149
Material Puncture/Hole 138 138
Material Twisted/Bent 136 136
Loose or Intermittent Connection 117 117
Inaccurate Delivery 115 115
Infusion or Flow Problem 102 102
Manufacturing, Packaging or Shipping Problem 101 101
Material Integrity Problem 95 95
Product Quality Problem 93 93
Improper or Incorrect Procedure or Method 92 92
Appropriate Term/Code Not Available 90 90
Difficult or Delayed Activation 88 88
Device Contaminated During Manufacture or Shipping 86 86
Bent 78 78
Dull, Blunt 72 72
Physical Property Issue 69 69
Material Discolored 68 68
Contamination 62 62
Insufficient Information 57 57
Unsealed Device Packaging 56 56
Use of Device Problem 55 55
Fungus in Device Environment 55 55
Gas Leak 55 55
Connection Problem 54 54
Insufficient Flow or Under Infusion 54 54
Incorrect, Inadequate or Imprecise Resultor Readings 54 54
Nonstandard Device 52 52
Illegible Information 51 51
Missing Information 50 50
Positioning Problem 49 49
Contamination of Device Ingredient or Reagent 49 49
Difficult to Advance 49 49
Retraction Problem 49 49
Obstruction of Flow 47 47
Structural Problem 47 47
Failure to Align 47 47
Fail-Safe Problem 43 43
Difficult to Remove 42 42
No Flow 41 41
Improper Flow or Infusion 40 40
Device Fell 36 36
Entrapment of Device 36 36
Particulates 34 34
Therapeutic or Diagnostic Output Failure 34 34
Device Operational Issue 33 33
Sticking 32 32
Fracture 32 32
Material Fragmentation 31 31
Inappropriate Audible Prompt/Feedback 31 31
Device Inoperable 30 30
Patient-Device Incompatibility 30 30
Melted 29 29
Physical Resistance 27 27
Free or Unrestricted Flow 26 26
Unintended Movement 26 26
Short Fill 26 26
Excess Flow or Over-Infusion 25 25
Wireless Communication Problem 25 25
Device Packaging Compromised 25 25
Device Displays Incorrect Message 25 25
Misconnection 24 24
Device Slipped 24 24
Device Difficult to Setup or Prepare 24 24
Moisture or Humidity Problem 23 23
Mechanics Altered 22 22
Activation, Positioning or SeparationProblem 22 22
Fitting Problem 22 22
Air Leak 22 22
Partial Blockage 22 22
Moisture Damage 20 20
Filling Problem 20 20
Tear, Rip or Hole in Device Packaging 20 20
Protective Measures Problem 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9869 9869
No Clinical Signs, Symptoms or Conditions 4484 4487
No Consequences Or Impact To Patient 3537 3537
No Patient Involvement 2018 2019
Hyperglycemia 942 942
Insufficient Information 571 571
No Information 466 466
Needle Stick/Puncture 363 363
Hypoglycemia 259 259
Pain 124 124
No Code Available 117 117
Foreign Body In Patient 87 87
Diabetic Ketoacidosis 85 85
Exposure to Body Fluids 76 76
Coma 70 70
Underdose 50 50
Missed Dose 49 49
Device Embedded In Tissue or Plaque 46 46
Chemical Exposure 40 40
Injury 35 35
Bruise/Contusion 32 32
Hemorrhage/Bleeding 28 28
Unspecified Infection 27 27
Visual Impairment 26 26
Vomiting 26 26
Swelling 25 25
High Blood Pressure/ Hypertension 25 25
Dizziness 24 24
Complaint, Ill-Defined 24 24
Overdose 23 23
Patient Problem/Medical Problem 21 21
Hypersensitivity/Allergic reaction 20 20
Vitreous Floaters 19 19
Blood Loss 18 18
Loss of consciousness 18 18
Reaction 18 18
Low Blood Pressure/ Hypotension 16 16
Inflammation 15 15
Blurred Vision 14 14
Fall 14 14
Numbness 14 14
Weight Changes 14 14
Laceration(s) 13 13
Nausea 13 13
Fatigue 12 12
Erythema 12 12
Fever 12 12
Shaking/Tremors 12 12
Discomfort 12 12
Itching Sensation 11 11
Eye Injury 10 10
Confusion/ Disorientation 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Abdominal Pain 9 9
Abscess 8 8
Infarction, Cerebral 8 8
Headache 8 8
Rash 8 8
Sepsis 8 8
Chills 8 8
Test Result 8 8
Sweating 8 8
Malaise 7 7
Ambulation Difficulties 7 7
Burning Sensation 7 7
Loss of Vision 7 7
Urinary Tract Infection 7 7
Seizures 7 7
Neuropathy 7 7
Emotional Changes 7 7
Dyspnea 6 6
Glaucoma 6 6
Bradycardia 6 6
Bacterial Infection 6 6
Memory Loss/Impairment 6 6
Retinal Injury 6 6
Visual Disturbances 6 6
Weakness 6 6
Not Applicable 6 6
Reaction, Injection Site 5 5
Syncope 5 5
Air Embolism 5 5
Death 5 5
Bone Fracture(s) 5 5
Fainting 5 5
Diarrhea 4 4
Purulent Discharge 4 4
Cardiac Arrest 4 4
Cataract 4 4
Arrhythmia 4 4
Skin Irritation 4 4
Tissue Damage 4 4
Thrombosis 4 4
Retinal Detachment 4 4
Electrolyte Imbalance 4 4
Skin Tears 4 4
Cognitive Changes 4 4
Unspecified Respiratory Problem 4 4
Syncope/Fainting 3 3
Injection Site Reaction 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Access Scientific LLC II May-14-2020
2 Arrow International Inc II Jan-24-2020
3 Arrow International Inc II May-30-2018
4 Becton Dickinson & Company II Feb-12-2021
5 Becton Dickinson & Company II Jul-22-2019
6 Becton Dickinson & Company II Nov-28-2017
7 Becton Dickinson & Company II Jul-19-2017
8 Cadence Science, Inc. II Nov-13-2019
9 Cypress Medical Products LLC II Oct-16-2018
10 Ethicon, Inc. II Apr-26-2018
11 ICU Medical, Inc. II Dec-23-2020
12 International Medsurg Connection, Inc. II Aug-04-2017
13 MICROVENTION INC. II Nov-04-2021
14 Medela Inc III Jul-23-2019
15 Merit Medical Systems, Inc. II Aug-10-2018
16 Merit Medical Systems, Inc. II Apr-27-2017
17 Novo Nordisk Inc II Dec-07-2017
18 ShinChang Medical Co., Ltd. II Sep-20-2018
19 Terumo BCT, Inc. II Nov-08-2017
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