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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 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
SPM MEDICARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 1375 1375

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 7491 7491
Device Contamination with Chemical or Other Material 4042 4043
Break 3018 3018
Patient Device Interaction Problem 1773 1773
Volume Accuracy Problem 1547 1547
Failure to Deliver 1404 1404
Device Markings/Labelling Problem 1340 1343
Computer Software Problem 1208 1208
Packaging Problem 680 680
Material Too Rigid or Stiff 661 661
Defective Component 617 617
Defective Device 598 598
Fluid/Blood Leak 594 594
Contamination 555 555
Crack 514 514
Detachment of Device or Device Component 439 439
Material Separation 367 367
Physical Resistance/Sticking 346 346
Material Deformation 338 338
Wireless Communication Problem 311 311
Delivered as Unsterile Product 304 304
Mechanical Jam 266 266
Adverse Event Without Identified Device or Use Problem 264 264
Appropriate Term/Code Not Available 230 230
Contamination /Decontamination Problem 227 227
Complete Blockage 214 214
Connection Problem 204 204
Inaccurate Delivery 202 202
Missing Information 189 189
Material Puncture/Hole 187 187
Insufficient Flow or Under Infusion 162 162
Product Quality Problem 149 149
Mechanical Problem 148 148
Material Protrusion/Extrusion 138 138
Failure to Align 129 129
Manufacturing, Packaging or Shipping Problem 125 125
Device Damaged Prior to Use 113 113
Material Twisted/Bent 110 110
Loose or Intermittent Connection 109 109
Improper or Incorrect Procedure or Method 104 104
Illegible Information 102 102
Insufficient Information 97 97
Battery Problem 88 88
Difficult or Delayed Activation 86 86
Dull, Blunt 76 76
Component Missing 74 74
Contamination of Device Ingredient or Reagent 66 66
Fracture 65 65
Nonstandard Device 65 65
Obstruction of Flow 64 64
Fungus in Device Environment 62 62
Material Integrity Problem 60 60
Incorrect, Inadequate or Imprecise Result or Readings 53 53
Excess Flow or Over-Infusion 50 50
Tear, Rip or Hole in Device Packaging 49 49
Use of Device Problem 49 49
No Flow 48 48
Inaccurate Information 47 47
Unsealed Device Packaging 45 45
Air/Gas in Device 44 44
Fail-Safe Problem 43 43
Infusion or Flow Problem 41 41
Gas/Air Leak 40 40
Material Discolored 40 40
Priming Problem 39 39
Device Contaminated During Manufacture or Shipping 38 38
Therapeutic or Diagnostic Output Failure 36 36
Separation Problem 36 36
Inappropriate Audible Prompt/Feedback 36 36
Unintended Movement 35 35
Improper Flow or Infusion 35 35
Device Fell 34 34
Short Fill 33 33
Partial Blockage 33 33
Device Alarm System 32 32
Moisture or Humidity Problem 31 31
Retraction Problem 30 30
Material Fragmentation 29 29
Melted 28 28
Misconnection 28 28
Free or Unrestricted Flow 26 26
Device Handling Problem 26 26
Fail-Safe Did Not Operate 25 25
Device Displays Incorrect Message 23 23
Deformation Due to Compressive Stress 22 22
Material Too Soft/Flexible 22 22
Incomplete or Inadequate Connection 21 21
No Apparent Adverse Event 21 21
Fitting Problem 21 21
Filling Problem 21 21
Mechanics Altered 20 20
Compatibility Problem 19 19
Difficult to Advance 19 19
Output Problem 18 18
Device Difficult to Setup or Prepare 18 18
Off-Label Use 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14775 14778
No Known Impact Or Consequence To Patient 6457 6457
No Consequences Or Impact To Patient 2514 2514
No Patient Involvement 1612 1613
Hyperglycemia 1373 1373
Insufficient Information 1022 1022
Hypoglycemia 331 331
Needle Stick/Puncture 324 324
No Information 296 296
Pain 131 131
Foreign Body In Patient 101 101
Diabetic Ketoacidosis 96 96
Coma 90 90
Exposure to Body Fluids 70 70
No Code Available 55 55
Underdose 35 35
Missed Dose 34 34
Device Embedded In Tissue or Plaque 33 33
Hemorrhage/Bleeding 33 33
Chemical Exposure 32 32
Bruise/Contusion 31 31
Loss of consciousness 26 26
Unspecified Infection 22 22
Laceration(s) 21 21
Injury 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Low Blood Pressure/ Hypotension 19 19
Hypersensitivity/Allergic reaction 18 18
Vomiting 17 17
Dizziness 16 16
Nausea 16 16
Blood Loss 15 15
Fatigue 14 14
Discomfort 14 14
Visual Impairment 14 14
Swelling 14 14
Fever 13 13
Inflammation 13 13
High Blood Pressure/ Hypertension 12 12
Reaction 12 12
Complaint, Ill-Defined 11 11
Overdose 11 11
Headache 11 11
Eye Injury 11 11
Fall 11 11
Injection Site Reaction 11 11
Vitreous Floaters 10 10
Bacterial Infection 10 10
Erythema 9 9
Numbness 9 9
Skin Inflammation/ Irritation 9 9
Polydipsia 9 9
Confusion/ Disorientation 9 9
Skin Tears 9 9
Patient Problem/Medical Problem 8 8
Convulsion/Seizure 8 8
Malaise 8 8
Chills 8 8
Abdominal Pain 7 7
Emotional Changes 7 7
Infarction, Cerebral 6 6
Air Embolism 6 6
Myocardial Infarction 6 6
Neuropathy 6 6
Sepsis 6 6
Speech Disorder 6 6
Unspecified Tissue Injury 6 6
Shaking/Tremors 6 6
Sweating 5 5
Ambulation Difficulties 5 5
Weight Changes 5 5
Loss of Vision 5 5
Visual Disturbances 5 5
Blurred Vision 5 5
Urinary Frequency 5 5
Electrolyte Imbalance 4 4
Reaction, Injection Site 4 4
Burning Sensation 4 4
Itching Sensation 4 4
Bone Fracture(s) 4 4
Cardiac Arrest 4 4
Diarrhea 4 4
Dyspnea 4 4
Swelling/ Edema 4 4
Syncope/Fainting 4 4
Unspecified Respiratory Problem 4 4
Thrombosis/Thrombus 3 3
Skin Infection 3 3
Sleep Dysfunction 3 3
Inadequate Osseointegration 3 3
Test Result 3 3
Cataract 3 3
Death 3 3
Abscess 3 3
Syncope 3 3
Hearing Impairment 3 3
Hematoma 3 3
Weakness 3 3
Retinal Injury 3 3
Scar Tissue 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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