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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, piston
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 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
AZUR MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 4
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BONUS THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 1
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
DLP MEDICAL PRODUCTS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
FLAT MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG ANTMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HWAJIN MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTERNATIONAL MEDICAL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JICHUN MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU KANGYOU MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SUYUN MEDICAL MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI MAIDIKANG MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
LIFELONG MEDITECH PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LIFENET HEALTH
  SUBSTANTIALLY EQUIVALENT 1
MD3 LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDONE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDWELL TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MILESTONE SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANUM COMPANY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG QINKAI MEDICAL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KOHOPE MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOL-MILLENNIUM MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 2
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOP CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3951 3951
2019 5862 5863
2020 5330 5330
2021 5868 5871
2022 5237 5237
2023 992 992

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 7386 7386
Device Contamination with Chemical or Other Material 4153 4154
Break 2913 2913
Volume Accuracy Problem 1442 1442
Device Markings/Labelling Problem 1333 1336
Patient Device Interaction Problem 1323 1323
Failure to Deliver 1263 1263
Computer Software Problem 799 799
Fluid/Blood Leak 740 740
Packaging Problem 629 629
Crack 581 581
Defective Device 567 567
Detachment of Device or Device Component 418 418
Contamination /Decontamination Problem 403 403
Defective Component 385 385
Material Deformation 359 359
Material Separation 306 306
Delivered as Unsterile Product 296 296
Physical Resistance/Sticking 287 287
Contamination 273 273
Adverse Event Without Identified Device or Use Problem 257 257
Mechanical Jam 234 234
Complete Blockage 203 203
Mechanical Problem 188 188
Wireless Communication Problem 173 173
Component Missing 170 170
Device Damaged Prior to Use 169 169
Material Puncture/Hole 162 162
Material Twisted/Bent 158 158
Material Protrusion/Extrusion 156 156
Appropriate Term/Code Not Available 156 156
Inaccurate Delivery 149 149
Device Operates Differently Than Expected 139 139
Connection Problem 137 137
Missing Information 134 134
Manufacturing, Packaging or Shipping Problem 132 132
Material Too Rigid or Stiff 128 128
Loose or Intermittent Connection 124 124
Product Quality Problem 123 123
Failure to Align 120 120
Detachment Of Device Component 99 99
Material Integrity Problem 96 96
Difficult or Delayed Activation 92 92
Insufficient Flow or Under Infusion 90 90
Improper or Incorrect Procedure or Method 84 84
Dull, Blunt 82 82
Illegible Information 81 81
Infusion or Flow Problem 78 78
Contamination of Device Ingredient or Reagent 72 72
Physical Property Issue 69 69
Material Discolored 66 66
Fungus in Device Environment 61 61
Insufficient Information 61 61
Device Contaminated During Manufacture or Shipping 60 60
Unsealed Device Packaging 59 59
Nonstandard Device 58 58
Obstruction of Flow 58 58
Incorrect, Inadequate or Imprecise Result or Readings 56 56
Bent 56 56
Use of Device Problem 55 55
Gas/Air Leak 55 55
Battery Problem 50 50
Fracture 48 48
Retraction Problem 45 45
Structural Problem 45 45
No Flow 45 45
Improper Flow or Infusion 42 42
Difficult to Advance 41 41
Inaccurate Information 40 40
Device Fell 40 40
Fail-Safe Problem 39 39
Excess Flow or Over-Infusion 39 39
Positioning Problem 38 38
Therapeutic or Diagnostic Output Failure 36 36
Melted 33 33
Short Fill 33 33
Inappropriate Audible Prompt/Feedback 32 32
Material Fragmentation 32 32
Mechanics Altered 32 32
Device Operational Issue 30 30
Tear, Rip or Hole in Device Packaging 30 30
Misconnection 29 29
Partial Blockage 28 28
Unintended Movement 28 28
Air/Gas in Device 28 28
Separation Problem 27 27
Moisture or Humidity Problem 27 27
Patient-Device Incompatibility 27 27
Difficult to Remove 27 27
Free or Unrestricted Flow 26 26
Device Alarm System 25 25
Device Slipped 24 24
Device Displays Incorrect Message 24 24
Fail-Safe Did Not Operate 24 24
Priming Problem 23 23
Filling Problem 23 23
Particulates 22 22
Device Difficult to Setup or Prepare 22 22
Output Problem 22 22
Fitting Problem 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9970 9973
No Known Impact Or Consequence To Patient 9080 9080
No Consequences Or Impact To Patient 3189 3189
No Patient Involvement 1739 1740
Hyperglycemia 1183 1183
Insufficient Information 827 827
No Information 424 424
Needle Stick/Puncture 313 313
Hypoglycemia 290 290
Pain 133 133
Foreign Body In Patient 99 99
No Code Available 87 87
Diabetic Ketoacidosis 85 85
Coma 83 83
Exposure to Body Fluids 73 73
Underdose 45 45
Missed Dose 39 39
Chemical Exposure 36 36
Device Embedded In Tissue or Plaque 34 34
Bruise/Contusion 31 31
Hemorrhage/Bleeding 29 29
Injury 29 29
Unspecified Infection 26 26
High Blood Pressure/ Hypertension 22 22
Hypersensitivity/Allergic reaction 21 21
Swelling 21 21
Patient Problem/Medical Problem 21 21
Loss of consciousness 20 20
Dizziness 19 19
Vomiting 17 17
Visual Impairment 17 17
Low Blood Pressure/ Hypotension 17 17
Fatigue 17 17
Inflammation 16 16
Laceration(s) 16 16
Blood Loss 16 16
Complaint, Ill-Defined 15 15
Reaction 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Overdose 15 15
Nausea 13 13
Fall 12 12
Fever 12 12
Vitreous Floaters 11 11
Erythema 11 11
Bacterial Infection 11 11
Numbness 10 10
Weight Changes 10 10
Confusion/ Disorientation 9 9
Shaking/Tremors 9 9
Headache 9 9
Blurred Vision 9 9
Discomfort 8 8
Chills 8 8
Itching Sensation 8 8
Eye Injury 8 8
Abscess 8 8
Air Embolism 8 8
Abdominal Pain 7 7
Sepsis 7 7
Loss of Vision 7 7
Sweating 7 7
Test Result 6 6
Speech Disorder 6 6
Burning Sensation 6 6
Retinal Injury 6 6
Infarction, Cerebral 6 6
Emotional Changes 6 6
Glaucoma 6 6
Cataract 5 5
Dyspnea 5 5
Syncope 5 5
Bradycardia 5 5
Seizures 5 5
Rash 5 5
Neuropathy 5 5
Visual Disturbances 5 5
Ambulation Difficulties 5 5
Injection Site Reaction 5 5
Skin Tears 4 4
Cognitive Changes 4 4
Reaction, Injection Site 4 4
Syncope/Fainting 4 4
Unspecified Respiratory Problem 4 4
Unspecified Tissue Injury 4 4
Urinary Tract Infection 4 4
Weakness 4 4
Electrolyte Imbalance 4 4
Memory Loss/Impairment 4 4
Arrhythmia 4 4
Diarrhea 4 4
Purulent Discharge 4 4
Hearing Impairment 3 3
Bone Fracture(s) 3 3
Abrasion 3 3
Death 3 3
Cardiac Arrest 3 3
Cardiopulmonary Arrest 3 3
Irritation 3 3
Thrombosis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Access Scientific LLC II May-14-2020
2 Allison Medical, Inc. II Dec-13-2022
3 Allison Medical, Inc. II Nov-18-2022
4 Arrow International Inc II Jan-24-2020
5 Arrow International Inc II May-30-2018
6 Becton Dickinson & Company II Mar-10-2023
7 Becton Dickinson & Company II Feb-12-2021
8 Becton Dickinson & Company II Jul-22-2019
9 Cadence Science, Inc. II Nov-13-2019
10 Cypress Medical Products LLC II Oct-16-2018
11 Ethicon, Inc. II Apr-26-2018
12 ICU Medical, Inc. II Dec-23-2020
13 MICROVENTION INC. II Nov-04-2021
14 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
15 Medela Inc III Jul-23-2019
16 Merit Medical Systems, Inc. II Aug-10-2018
17 ShinChang Medical Co., Ltd. II Sep-20-2018
18 Stradis Healthcare II Jan-11-2023
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