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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
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 5
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOMET BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BONUS THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
COMPANION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCEPTOMED AS
  SUBSTANTIALLY EQUIVALENT 2
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
ELI LILLY AND COMPANY, INC.
  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
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 2
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 2
SIO2 MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SUNG SHIM MEDICARE CO., LTD.
  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
2016 684 684
2017 1857 1857
2018 3951 3951
2019 5862 5863
2020 5330 5330
2021 4126 4129

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6632 6632
Device Contamination with Chemical or Other Material 3836 3837
Break 1924 1924
Device Markings/Labelling Problem 1196 1199
Volume Accuracy Problem 1140 1140
Failure to Deliver 1044 1044
Fluid Leak 786 786
Packaging Problem 550 550
Crack 499 499
Defective Device 459 459
Device Operates Differently Than Expected 433 433
Contamination /Decontamination Problem 372 372
Patient Device Interaction Problem 341 341
Adverse Event Without Identified Device or Use Problem 271 271
Delivered as Unsterile Product 246 246
Computer Software Problem 235 235
Material Deformation 223 223
Detachment Of Device Component 205 205
Component Missing 201 201
Device Damaged Prior to Use 194 194
Detachment of Device or Device Component 190 190
Material Separation 174 174
Mechanical Problem 168 168
Physical Resistance/Sticking 163 163
Material Protrusion/Extrusion 147 147
Mechanical Jam 143 143
Defective Component 139 139
Material Puncture/Hole 135 135
Material Twisted/Bent 130 130
Complete Blockage 128 128
Loose or Intermittent Connection 112 112
Inaccurate Delivery 110 110
Improper or Incorrect Procedure or Method 105 105
Infusion or Flow Problem 103 103
Material Integrity Problem 95 95
Appropriate Term/Code Not Available 94 94
Manufacturing, Packaging or Shipping Problem 93 93
Product Quality Problem 91 91
Device Contaminated During Manufacture or Shipping 86 86
Bent 85 85
Difficult or Delayed Activation 82 82
Insufficient Information 81 81
Dull, Blunt 71 71
Physical Property Issue 69 69
Material Discolored 68 68
Contamination 61 61
Use of Device Problem 59 59
Connection Problem 56 56
Gas Leak 55 55
Nonstandard Device 53 53
Unsealed Device Packaging 52 52
Incorrect, Inadequate or Imprecise Resultor Readings 52 52
Positioning Problem 52 52
Contamination of Device Ingredient or Reagent 51 51
Retraction Problem 51 51
Difficult to Advance 50 50
Insufficient Flow or Under Infusion 50 50
Fungus in Device Environment 49 49
Structural Problem 49 49
No Flow 48 48
Failure to Align 47 47
Fail-Safe Problem 47 47
Obstruction of Flow 46 46
Difficult to Remove 46 46
Sticking 45 45
Illegible Information 42 42
Device Inoperable 40 40
Improper Flow or Infusion 39 39
Therapeutic or Diagnostic Output Failure 36 36
Particulates 36 36
Entrapment of Device 36 36
Material Fragmentation 35 35
Device Operational Issue 35 35
Physical Resistance 32 32
Air Leak 32 32
Device Fell 32 32
Patient-Device Incompatibility 31 31
Excess Flow or Over-Infusion 30 30
Inappropriate Audible Prompt/Feedback 29 29
Device Slipped 28 28
Device Displays Incorrect Message 28 28
Melted 27 27
Device Packaging Compromised 27 27
Short Fill 26 26
Protective Measures Problem 25 25
Fracture 24 24
Misconnection 24 24
Free or Unrestricted Flow 24 24
Unintended Movement 23 23
Device Difficult to Setup or Prepare 23 23
Missing Information 22 22
Fitting Problem 22 22
Moisture Damage 21 21
Mechanics Altered 21 21
Moisture or Humidity Problem 21 21
Tear, Rip or Hole in Device Packaging 21 21
Device Dislodged or Dislocated 21 21
Activation, Positioning or SeparationProblem 21 21
Component Falling 20 20
Fail-Safe Did Not Operate 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10056 10056
No Consequences Or Impact To Patient 3566 3566
No Clinical Signs, Symptoms or Conditions 3092 3095
No Patient Involvement 2080 2081
Hyperglycemia 1024 1024
No Information 502 502
Insufficient Information 457 457
Needle Stick/Puncture 389 389
Hypoglycemia 304 304
No Code Available 148 148
Pain 125 125
Diabetic Ketoacidosis 91 91
Foreign Body In Patient 88 88
Exposure to Body Fluids 81 81
Coma 76 76
Underdose 56 56
Device Embedded In Tissue or Plaque 54 54
Missed Dose 50 50
High Blood Pressure/ Hypertension 47 47
Injury 47 47
Visual Impairment 40 40
Chemical Exposure 38 38
Complaint, Ill-Defined 35 35
Unspecified Infection 33 33
Hemorrhage/Bleeding 33 33
Bruise/Contusion 32 32
Vomiting 32 32
Swelling 32 32
Dizziness 31 31
Overdose 31 31
Blurred Vision 25 25
Blood Loss 25 25
Fall 25 25
Patient Problem/Medical Problem 22 22
Reaction 21 21
Hypersensitivity/Allergic reaction 21 21
Vitreous Floaters 20 20
Loss of consciousness 20 20
Low Blood Pressure/ Hypotension 18 18
Discomfort 18 18
Weight Changes 18 18
Itching Sensation 16 16
Fever 16 16
Inflammation 15 15
Numbness 15 15
Fatigue 14 14
Nausea 14 14
Death 14 15
Eye Injury 14 14
Shaking/Tremors 14 14
Erythema 13 13
Fainting 13 13
Cataract 12 12
Weakness 12 12
Confusion/ Disorientation 11 11
Infarction, Cerebral 11 11
Laceration(s) 11 11
Rash 11 11
Ambulation Difficulties 10 10
Seizures 10 10
Loss of Vision 10 10
Test Result 10 10
Urinary Tract Infection 9 9
Abdominal Pain 9 9
Sweating 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Neuropathy 9 9
Chills 8 8
Abscess 8 8
Emotional Changes 8 8
Headache 8 8
Burning Sensation 8 8
Bacterial Infection 7 7
Cardiac Arrest 7 8
Bradycardia 7 7
Myocardial Infarction 7 7
Dyspnea 7 8
Malaise 7 7
Memory Loss/Impairment 7 7
Sepsis 7 7
Visual Disturbances 7 7
Reaction, Injection Site 6 6
Retinal Injury 6 6
Glaucoma 6 6
Hearing Impairment 6 6
Hearing Loss 6 6
Syncope 6 6
Stroke/CVA 6 6
Not Applicable 6 6
Bone Fracture(s) 5 5
Diarrhea 5 5
Tissue Damage 5 5
Retinal Detachment 5 5
Air Embolism 5 5
Skin Irritation 5 5
Irritation 4 4
Thrombosis 4 4
Hematoma 4 4
Cognitive Changes 4 4
Sleep Dysfunction 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 Baxter Corporation Englewood II Jan-30-2016
5 Becton Dickinson & Company II Feb-12-2021
6 Becton Dickinson & Company II Jul-22-2019
7 Becton Dickinson & Company II Nov-28-2017
8 Becton Dickinson & Company II Jul-19-2017
9 Becton Dickinson & Company II Jun-09-2016
10 Biomet, Inc. II May-25-2016
11 Cadence Science, Inc. II Nov-13-2019
12 Cypress Medical Products LLC II Oct-16-2018
13 Ethicon, Inc. II Apr-26-2018
14 ICU Medical, Inc. II Dec-23-2020
15 International Medsurg Connection, Inc. II Aug-04-2017
16 Medela Inc III Jul-23-2019
17 Merit Medical Systems, Inc. II Aug-10-2018
18 Merit Medical Systems, Inc. II Apr-27-2017
19 Novo Nordisk Inc II Dec-07-2017
20 ShinChang Medical Co., Ltd. II Sep-20-2018
21 Terumo BCT, Inc. II Nov-08-2017
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