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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
ANUTRA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 6
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 5
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 5
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ELI LILLY AND CO.
  SUBSTANTIALLY EQUIVALENT 1
ELI LILLY AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGYIN CAINA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NOVO NORDISK INC.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROCEDURE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROFIBRIX BV
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KOHOPE MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TERUMO EUROPE N.V.
  SUBSTANTIALLY EQUIVALENT 1
TOP CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UROGEN PHARMA LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 273 273
2016 683 683
2017 1857 1857
2018 3949 3949
2019 5862 5862
2020 4250 4250

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4669 4669
Device Contamination with Chemical or Other Material 3059 3059
Break 1437 1437
Device Markings/Labelling Problem 964 964
Volume Accuracy Problem 728 728
Fluid Leak 728 728
Failure to Deliver 661 661
Crack 481 481
Device Operates Differently Than Expected 462 462
Plunger 416 416
Packaging Problem 408 408
Needle 375 375
Contamination /Decontamination Problem 371 371
Defective Device 335 335
Tip 324 324
Syringe 315 315
Adverse Event Without Identified Device or Use Problem 241 241
Detachment Of Device Component 219 219
Delivered as Unsterile Product 218 218
Component Missing 194 194
Device Damaged Prior to Use 192 192
Material Deformation 183 183
Detachment of Device or Device Component 181 181
Mechanical Problem 143 143
Physical Resistance/Sticking 124 124
Material Protrusion/Extrusion 117 117
Defective Component 109 109
Improper or Incorrect Procedure or Method 106 106
Material Puncture/Hole 106 106
Material Twisted/Bent 102 102
Insufficient Information 102 102
Loose or Intermittent Connection 99 99
Infusion or Flow Problem 98 98
Material Separation 98 98
Mechanical Jam 95 95
Bent 89 89
Switch, Push Button 86 86
Material Integrity Problem 85 85
Product Quality Problem 84 84
Manufacturing, Packaging or Shipping Problem 83 83
Cap 83 83
Device Contaminated During Manufacture or Shipping 80 80
Complete Blockage 79 79
Inaccurate Delivery 75 75
Appropriate Term/Code Not Available 69 69
Physical Property Issue 69 69
Difficult or Delayed Activation 68 68
Dull, Blunt 65 65
Material Discolored 65 65
Rod 65 65
None 62 62
Gas Leak 53 53
Retraction Problem 53 53
Nonstandard Device 52 52
Contamination of Device Ingredient or Reagent 51 51
Positioning Problem 50 50
Sticking 50 50
Unsealed Device Packaging 50 50
Difficult to Remove 49 49
Use of Device Problem 49 49
Difficult to Advance 47 47
Screw 46 46
Structural Problem 45 45
Failure to Align 44 44
Hub 44 44
Device Inoperable 43 43
No Flow 43 43
Contamination 41 41
Fail-Safe Problem 38 38
Fungus in Device Environment 38 38
Entrapment of Device 37 37
Obstruction of Flow 37 37
Particulates 37 37
Incorrect, Inadequate or Imprecise Resultor Readings 36 36
Material Fragmentation 36 36
Improper Flow or Infusion 36 36
Device Operational Issue 35 35
Connection Problem 35 35
Physical Resistance 34 34
Air Leak 34 34
Holder 32 32
Therapeutic or Diagnostic Output Failure 32 32
Patient-Device Incompatibility 30 30
Device Packaging Compromised 29 29
Device Slipped 28 28
Protective Measures Problem 27 27
Illegible Information 27 27
Melted 26 26
Excess Flow or Over-Infusion 26 26
Device Displays Incorrect Message 26 26
Device Dislodged or Dislocated 23 23
Device Difficult to Setup or Prepare 22 22
Component Falling 22 22
Moisture Damage 21 21
Moisture or Humidity Problem 21 21
Free or Unrestricted Flow 20 20
Activation, Positioning or SeparationProblem 20 20
Mechanics Altered 19 19
Tear, Rip or Hole in Device Packaging 19 19
Short Fill 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10134 10134
No Consequences Or Impact To Patient 2282 2282
No Patient Involvement 1734 1734
Hyperglycemia 814 814
No Information 517 517
Needle Stick/Puncture 330 330
Hypoglycemia 287 287
No Code Available 152 152
Pain 114 114
Diabetic Ketoacidosis 77 77
Foreign Body In Patient 72 72
Device Embedded In Tissue or Plaque 65 65
Exposure to Body Fluids 63 63
Underdose 62 62
Coma 59 59
Missed Dose 50 50
Injury 50 50
High Blood Pressure/ Hypertension 47 47
Visual Impairment 38 38
Complaint, Ill-Defined 35 35
Swelling 34 34
No Clinical Signs, Symptoms or Conditions 34 34
Dizziness 33 33
Unspecified Infection 33 33
Hemorrhage/Bleeding 32 32
Overdose 32 32
Vomiting 32 32
Chemical Exposure 32 32
Bruise/Contusion 28 28
Fall 27 27
Blurred Vision 26 26
Blood Loss 23 23
Abscess 23 23
Patient Problem/Medical Problem 22 22
Weight Changes 19 19
Vitreous Floaters 19 19
Loss of consciousness 19 19
Insufficient Information 18 18
Discomfort 18 18
Reaction 18 18
Itching Sensation 17 17
Inflammation 17 17
Low Blood Pressure/ Hypotension 16 16
Numbness 16 16
Weakness 16 16
Shaking/Tremors 15 15
Death 15 16
Fainting 14 14
Erythema 13 13
Hypersensitivity/Allergic reaction 13 13
Eye Injury 13 13
Nausea 12 12
Confusion/ Disorientation 12 12
Rash 12 12
Fatigue 12 12
Cataract 12 12
Infarction, Cerebral 11 11
Urinary Tract Infection 10 10
Seizures 10 10
Test Result 10 10
Sweating 10 10
Ambulation Difficulties 10 10
Fever 9 9
Neuropathy 9 9
Burning Sensation 9 9
Loss of Vision 9 9
Tissue Damage 9 9
Laceration(s) 9 9
Abdominal Pain 8 8
Malaise 8 8
Visual Disturbances 7 7
Memory Loss/Impairment 7 7
Emotional Changes 7 7
Cardiac Arrest 7 8
Stroke/CVA 7 7
Not Applicable 7 7
Anxiety 6 6
Bone Fracture(s) 6 6
Headache 6 6
Bradycardia 6 6
Myocardial Infarction 6 6
Dyspnea 6 7
Glaucoma 6 6
Hearing Impairment 6 6
Hearing Loss 6 6
Hematoma 6 6
Sepsis 6 6
Reaction, Injection Site 6 6
Skin Irritation 5 5
Retinal Detachment 5 5
Syncope 5 5
Diarrhea 5 5
Shock, Insulin 5 5
Arthralgia 4 4
Radiation Exposure, Unintended 4 4
Purulent Discharge 4 4
Head Injury 4 4
Anaphylactic Shock 4 5
Arrhythmia 4 4
Bacterial Infection 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 Jul-22-2019
6 Becton Dickinson & Company II Nov-28-2017
7 Becton Dickinson & Company II Jul-19-2017
8 Becton Dickinson & Company II Jun-09-2016
9 Becton Dickinson & Company II Feb-05-2015
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 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Oct-30-2015
15 International Medsurg Connection, Inc. II Aug-04-2017
16 Medela Inc III Jul-23-2019
17 Medela Inc. EF Division II Mar-11-2015
18 Merit Medical Systems, Inc. II Aug-10-2018
19 Merit Medical Systems, Inc. II Apr-27-2017
20 Novo Nordisk Inc II Dec-07-2017
21 Owen Mumford USA, Inc. II Jul-15-2015
22 ShinChang Medical Co., Ltd. II Sep-20-2018
23 Terumo BCT, Inc. II Nov-08-2017
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