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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
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 4
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG ANTMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTERNATIONAL MEDICAL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERVENE GROUP LTD
  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 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
MEDEX
  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 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
PROCEDURE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
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 1
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KOHOPE MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 5868 5871
2022 3390 3390

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 7261 7261
Device Contamination with Chemical or Other Material 4482 4483
Break 2623 2623
Volume Accuracy Problem 1385 1385
Device Markings/Labelling Problem 1322 1325
Failure to Deliver 1222 1222
Patient Device Interaction Problem 963 963
Fluid Leak 841 841
Packaging Problem 608 608
Crack 593 593
Defective Device 537 537
Computer Software Problem 489 489
Contamination /Decontamination Problem 400 400
Detachment of Device or Device Component 394 394
Defective Component 338 338
Material Deformation 336 336
Device Operates Differently Than Expected 315 315
Delivered as Unsterile Product 284 284
Adverse Event Without Identified Device or Use Problem 281 281
Material Separation 264 264
Physical Resistance/Sticking 236 236
Mechanical Jam 213 213
Device Damaged Prior to Use 208 208
Component Missing 201 201
Mechanical Problem 193 193
Detachment Of Device Component 185 185
Complete Blockage 179 179
Material Protrusion/Extrusion 163 163
Material Puncture/Hole 154 154
Material Twisted/Bent 148 148
Inaccurate Delivery 139 139
Loose or Intermittent Connection 125 125
Contamination 123 123
Manufacturing, Packaging or Shipping Problem 118 118
Appropriate Term/Code Not Available 117 117
Connection Problem 109 109
Product Quality Problem 108 108
Infusion or Flow Problem 102 102
Missing Information 101 101
Material Integrity Problem 100 100
Improper or Incorrect Procedure or Method 99 99
Failure to Align 93 93
Difficult or Delayed Activation 92 92
Device Contaminated During Manufacture or Shipping 91 91
Dull, Blunt 79 79
Bent 78 78
Insufficient Flow or Under Infusion 74 74
Material Discolored 72 72
Unsealed Device Packaging 69 69
Physical Property Issue 69 69
Illegible Information 66 66
Wireless Communication Problem 65 65
Fungus in Device Environment 59 59
Use of Device Problem 58 58
Insufficient Information 58 58
Contamination of Device Ingredient or Reagent 58 58
Incorrect, Inadequate or Imprecise Resultor Readings 56 56
Nonstandard Device 55 55
Gas Leak 55 55
Obstruction of Flow 53 53
Retraction Problem 53 53
Difficult to Advance 50 50
Positioning Problem 49 49
Structural Problem 48 48
Fail-Safe Problem 46 46
No Flow 45 45
Difficult to Remove 43 43
Improper Flow or Infusion 41 41
Device Fell 40 40
Fracture 40 40
Entrapment of Device 38 38
Particulates 36 36
Therapeutic or Diagnostic Output Failure 36 36
Material Fragmentation 35 35
Melted 33 33
Excess Flow or Over-Infusion 33 33
Device Operational Issue 33 33
Inappropriate Audible Prompt/Feedback 32 32
Sticking 32 32
Device Inoperable 30 30
Short Fill 30 30
Patient-Device Incompatibility 30 30
Mechanics Altered 29 29
Inaccurate Information 29 29
Partial Blockage 29 29
Misconnection 28 28
Unintended Movement 28 28
Moisture or Humidity Problem 27 27
Device Displays Incorrect Message 27 27
Physical Resistance 27 27
Tear, Rip or Hole in Device Packaging 27 27
Device Slipped 26 26
Free or Unrestricted Flow 26 26
Device Packaging Compromised 25 25
Fail-Safe Did Not Operate 24 24
Device Difficult to Setup or Prepare 24 24
Fitting Problem 24 24
Filling Problem 23 23
Air Leak 22 22
Output Problem 22 22

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 7406 7409
No Consequences Or Impact To Patient 3537 3537
No Patient Involvement 2018 2019
Hyperglycemia 1143 1143
Insufficient Information 801 801
No Information 466 466
Needle Stick/Puncture 388 388
Hypoglycemia 300 300
Pain 137 137
No Code Available 117 117
Foreign Body In Patient 98 98
Diabetic Ketoacidosis 95 95
Exposure to Body Fluids 79 79
Coma 77 77
Underdose 50 50
Missed Dose 49 49
Device Embedded In Tissue or Plaque 47 47
Chemical Exposure 40 40
Injury 35 35
Bruise/Contusion 33 33
Unspecified Infection 32 32
Hemorrhage/Bleeding 31 31
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
Loss of consciousness 22 22
Patient Problem/Medical Problem 21 21
Hypersensitivity/Allergic reaction 21 21
Vitreous Floaters 19 19
Blood Loss 18 18
Reaction 18 18
Low Blood Pressure/ Hypotension 17 17
Laceration(s) 16 16
Fall 16 16
Inflammation 15 15
Nausea 14 14
Blurred Vision 14 14
Numbness 14 14
Weight Changes 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Fatigue 13 13
Erythema 12 12
Eye Injury 12 12
Fever 12 12
Shaking/Tremors 12 12
Discomfort 12 12
Itching Sensation 11 11
Bacterial Infection 10 10
Confusion/ Disorientation 10 10
Abdominal Pain 9 9
Headache 9 9
Abscess 8 8
Air Embolism 8 8
Infarction, Cerebral 8 8
Rash 8 8
Chills 8 8
Sepsis 8 8
Sweating 8 8
Test Result 8 8
Ambulation Difficulties 7 7
Malaise 7 7
Seizures 7 7
Urinary Tract Infection 7 7
Burning Sensation 7 7
Loss of Vision 7 7
Neuropathy 7 7
Emotional Changes 7 7
Dyspnea 6 6
Glaucoma 6 6
Bradycardia 6 6
Retinal Injury 6 6
Memory Loss/Impairment 6 6
Visual Disturbances 6 6
Weakness 6 6
Not Applicable 6 6
Speech Disorder 6 6
Injection Site Reaction 5 5
Reaction, Injection Site 5 5
Death 5 5
Syncope 5 5
Bone Fracture(s) 5 5
Fainting 5 5
Diarrhea 4 4
Purulent Discharge 4 4
Arrhythmia 4 4
Cardiac Arrest 4 4
Cataract 4 4
Electrolyte Imbalance 4 4
Tissue Damage 4 4
Thrombosis 4 4
Skin Irritation 4 4
Retinal Detachment 4 4
Skin Tears 4 4
Cognitive Changes 4 4
Unspecified Respiratory Problem 4 4

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 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 Merit Medical Systems, Inc. II Apr-27-2017
18 Novo Nordisk Inc II Dec-07-2017
19 ShinChang Medical Co., Ltd. II Sep-20-2018
20 Terumo BCT, Inc. II Nov-08-2017
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