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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 HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
AVITUS ORTHOPAEDICS, INC.
  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 3
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
ELCAM MEDICAL ACAL
  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
GUIDESTAR MEDICAL DEVICES
  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
JIANGSU ZHIYU MEDICAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI MAIDIKANG MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
LIFELONG MEDITECH PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
LIFENET HEALTH
  SUBSTANTIALLY EQUIVALENT 1
LINEAGE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MD3 LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDONE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDWELL TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
MILESTONE SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANUM COMPANY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMEQ MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBIT BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
REVITAL HEALTHCARE (EPZ) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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 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
SMB CORPORATION OF INDIA
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOP CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI SHENGJIE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WEPON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5862 5863
2020 5330 5330
2021 5868 5871
2022 5232 5232
2023 5222 5222
2024 493 493

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 7411 7411
Device Contamination with Chemical or Other Material 3905 3906
Break 2930 2930
Patient Device Interaction Problem 1713 1713
Volume Accuracy Problem 1512 1512
Failure to Deliver 1375 1375
Device Markings/Labelling Problem 1304 1307
Computer Software Problem 1142 1142
Packaging Problem 664 664
Material Too Rigid or Stiff 593 593
Defective Device 578 578
Fluid/Blood Leak 575 575
Defective Component 566 566
Contamination 517 517
Crack 499 499
Detachment of Device or Device Component 397 397
Material Separation 363 363
Physical Resistance/Sticking 345 345
Material Deformation 330 330
Delivered as Unsterile Product 302 302
Wireless Communication Problem 293 293
Mechanical Jam 262 262
Adverse Event Without Identified Device or Use Problem 258 258
Contamination /Decontamination Problem 226 226
Complete Blockage 213 213
Inaccurate Delivery 196 196
Appropriate Term/Code Not Available 196 196
Missing Information 187 187
Connection Problem 183 183
Material Puncture/Hole 180 180
Insufficient Flow or Under Infusion 150 150
Product Quality Problem 144 144
Mechanical Problem 141 141
Material Protrusion/Extrusion 138 138
Failure to Align 126 126
Manufacturing, Packaging or Shipping Problem 118 118
Device Damaged Prior to Use 113 113
Material Twisted/Bent 109 109
Loose or Intermittent Connection 108 108
Improper or Incorrect Procedure or Method 100 100
Illegible Information 100 100
Insufficient Information 94 94
Difficult or Delayed Activation 85 85
Battery Problem 81 81
Dull, Blunt 73 73
Component Missing 72 72
Contamination of Device Ingredient or Reagent 66 66
Obstruction of Flow 64 64
Fungus in Device Environment 62 62
Fracture 60 60
Nonstandard Device 59 59
Material Integrity Problem 56 56
Incorrect, Inadequate or Imprecise Result or Readings 52 52
Use of Device Problem 49 49
Tear, Rip or Hole in Device Packaging 48 48
Excess Flow or Over-Infusion 47 47
Inaccurate Information 47 47
Unsealed Device Packaging 45 45
No Flow 44 44
Air/Gas in Device 42 42
Material Discolored 40 40
Priming Problem 39 39
Fail-Safe Problem 39 39
Gas/Air Leak 38 38
Infusion or Flow Problem 37 37
Device Contaminated During Manufacture or Shipping 37 37
Therapeutic or Diagnostic Output Failure 36 36
Separation Problem 36 36
Inappropriate Audible Prompt/Feedback 36 36
Unintended Movement 35 35
Device Fell 34 34
Short Fill 33 33
Partial Blockage 33 33
Device Alarm System 32 32
Improper Flow or Infusion 31 31
Moisture or Humidity Problem 30 30
Retraction Problem 30 30
Melted 28 28
Misconnection 28 28
Material Fragmentation 27 27
Free or Unrestricted Flow 26 26
Device Handling Problem 25 25
Fail-Safe Did Not Operate 25 25
Incomplete or Inadequate Connection 21 21
Fitting Problem 21 21
Deformation Due to Compressive Stress 21 21
Device Displays Incorrect Message 20 20
Filling Problem 20 20
No Apparent Adverse Event 20 20
Mechanics Altered 20 20
Compatibility Problem 19 19
Difficult to Advance 19 19
Material Too Soft/Flexible 19 19
Output Problem 18 18
Device Difficult to Setup or Prepare 18 18
Patient-Device Incompatibility 18 18
Structural Problem 18 18
Difficult to Remove 16 16
Labelling, Instructions for Use or Training Problem 16 16
Microbial Contamination of Device 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13993 13996
No Known Impact Or Consequence To Patient 6457 6457
No Consequences Or Impact To Patient 2514 2514
No Patient Involvement 1612 1613
Hyperglycemia 1327 1327
Insufficient Information 1001 1001
Hypoglycemia 321 321
Needle Stick/Puncture 313 313
No Information 296 296
Pain 126 126
Foreign Body In Patient 98 98
Diabetic Ketoacidosis 91 91
Coma 89 89
Exposure to Body Fluids 70 70
No Code Available 55 55
Underdose 35 35
Missed Dose 34 34
Chemical Exposure 32 32
Device Embedded In Tissue or Plaque 32 32
Hemorrhage/Bleeding 31 31
Bruise/Contusion 31 31
Loss of consciousness 26 26
Unspecified Infection 22 22
Injury 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Low Blood Pressure/ Hypotension 18 18
Hypersensitivity/Allergic reaction 18 18
Laceration(s) 18 18
Vomiting 17 17
Dizziness 16 16
Blood Loss 15 15
Nausea 15 15
Visual Impairment 14 14
Swelling 14 14
Fatigue 14 14
Discomfort 14 14
Fever 13 13
Inflammation 13 13
Reaction 12 12
High Blood Pressure/ Hypertension 12 12
Headache 11 11
Fall 11 11
Overdose 11 11
Injection Site Reaction 11 11
Eye Injury 11 11
Complaint, Ill-Defined 11 11
Vitreous Floaters 10 10
Bacterial Infection 10 10
Skin Inflammation/ Irritation 9 9
Numbness 9 9
Polydipsia 9 9
Confusion/ Disorientation 9 9
Chills 8 8
Convulsion/Seizure 8 8
Patient Problem/Medical Problem 8 8
Skin Tears 8 8
Erythema 7 7
Malaise 7 7
Abdominal Pain 7 7
Emotional Changes 6 6
Sepsis 6 6
Neuropathy 6 6
Air Embolism 6 6
Shaking/Tremors 6 6
Speech Disorder 6 6
Infarction, Cerebral 6 6
Blurred Vision 5 5
Loss of Vision 5 5
Weight Changes 5 5
Myocardial Infarction 5 5
Urinary Frequency 5 5
Sweating 5 5
Visual Disturbances 5 5
Ambulation Difficulties 5 5
Itching Sensation 4 4
Diarrhea 4 4
Cardiac Arrest 4 4
Dyspnea 4 4
Syncope/Fainting 4 4
Unspecified Respiratory Problem 4 4
Reaction, Injection Site 4 4
Burning Sensation 4 4
Electrolyte Imbalance 4 4
Bone Fracture(s) 4 4
Unspecified Tissue Injury 4 4
Death 3 3
Skin Infection 3 3
Thrombosis/Thrombus 3 3
Syncope 3 3
Test Result 3 3
Inadequate Osseointegration 3 3
Weakness 3 3
Scar Tissue 3 3
Hearing Impairment 3 3
Sleep Dysfunction 3 3
Swelling/ Edema 3 3
Hematoma 3 3
Retinal Injury 3 3
Paralysis 3 3
Abscess 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 B. Braun Medical, Inc. II Sep-27-2023
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 Cardinal Health 200, LLC I Feb-02-2024
11 Cardinal Health 200, LLC I Oct-26-2023
12 Cardinal Health 200, LLC II Oct-13-2023
13 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
14 ICU Medical, Inc. II Dec-23-2020
15 MICROVENTION INC. II Nov-04-2021
16 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
17 Medela Inc III Jul-23-2019
18 Stradis Healthcare II Jan-11-2023
19 Wolf, Henke Sass, Gmbh II Sep-27-2023
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