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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 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 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOVENTUS LLC
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 2
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
DLP MEDICAL PRODUCTS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K221737  InstaFill Graft Delivery System, SIGNIFY Bioactive
GO-PEN APS
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG ANTMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUIDESTAR MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HLB LIFESCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HWAJIN MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL MEDICAL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMEQ MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBIT BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERFECT MEDICAL INDUSTRY (VN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
PROSIDYAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMB CORPORATION OF INDIA
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
SPM MEDICARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 2
SURGENTEC, LLC.
  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
WUXI NEST BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5330 5330
2021 5868 5871
2022 5233 5233
2023 5222 5222
2024 5125 5125
2025 985 985

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5851 5851
Device Contamination with Chemical or Other Material 3687 3687
Break 3045 3045
Patient Device Interaction Problem 2151 2151
Computer Software Problem 1430 1430
Volume Accuracy Problem 1400 1400
Device Markings/Labelling Problem 1310 1313
Failure to Deliver 1273 1273
Material Too Rigid or Stiff 908 908
Defective Component 883 883
Contamination 687 687
Defective Device 589 589
Packaging Problem 587 587
Crack 496 496
Fluid/Blood Leak 462 462
Detachment of Device or Device Component 411 411
Material Separation 372 372
Wireless Communication Problem 359 359
Physical Resistance/Sticking 327 327
Material Deformation 311 311
Appropriate Term/Code Not Available 304 304
Connection Problem 287 287
Mechanical Jam 282 282
Insufficient Information 276 276
Adverse Event Without Identified Device or Use Problem 241 241
Inaccurate Delivery 238 238
Insufficient Flow or Under Infusion 210 210
Missing Information 199 199
Complete Blockage 198 198
Delivered as Unsterile Product 196 196
Product Quality Problem 186 186
Material Puncture/Hole 175 175
Manufacturing, Packaging or Shipping Problem 160 160
Failure to Align 144 144
Mechanical Problem 138 138
Improper or Incorrect Procedure or Method 125 125
Contamination /Decontamination Problem 117 117
Battery Problem 115 115
Loose or Intermittent Connection 101 101
Illegible Information 100 100
Material Twisted/Bent 99 99
Material Protrusion/Extrusion 96 96
Material Integrity Problem 92 92
Dull, Blunt 87 87
Off-Label Use 83 83
Fracture 78 78
Difficult or Delayed Activation 68 68
Obstruction of Flow 56 56
Component Missing 54 54
No Flow 52 52

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18841 18844
No Consequences Or Impact To Patient 2332 2332
No Known Impact Or Consequence To Patient 1831 1831
Hyperglycemia 1541 1541
No Patient Involvement 1361 1361
Insufficient Information 1175 1175
Hypoglycemia 341 341
Needle Stick/Puncture 281 281
Diabetic Ketoacidosis 108 108
Foreign Body In Patient 105 105
Pain 104 104
Coma 87 87
Exposure to Body Fluids 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Loss of consciousness 29 29
Chemical Exposure 28 28
Hemorrhage/Bleeding 24 24
Laceration(s) 22 22
No Code Available 20 20
Low Blood Pressure/ Hypotension 20 20
Fatigue 19 19
Nausea 19 19
No Information 19 19
Device Embedded In Tissue or Plaque 18 18
Bruise/Contusion 17 17
Missed Dose 16 16
Fever 15 15
Vomiting 14 14
Injection Site Reaction 14 14
Hypersensitivity/Allergic reaction 14 14
Underdose 14 14
Unspecified Infection 13 13
Discomfort 12 12
Skin Inflammation/ Irritation 12 12
Bacterial Infection 10 10
Polydipsia 10 10
Overdose 9 9
Eye Injury 9 9
Dizziness 9 9
Headache 8 8
Injury 8 8
Chills 8 8
Convulsion/Seizure 8 8
Skin Tears 8 8
Malaise 8 8
Unspecified Tissue Injury 7 7
Abdominal Pain 7 7
Myocardial Infarction 7 7
Reaction 7 7
Air Embolism 7 7

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 Cardinal Health 200, LLC I Feb-02-2024
9 Cardinal Health 200, LLC I Oct-26-2023
10 Cardinal Health 200, LLC II Oct-13-2023
11 Cypress Medical Products LLC II Sep-16-2024
12 Cypress Medical Products LLC II Aug-29-2024
13 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
14 ICU Medical, Inc. II Dec-23-2020
15 Jiangsu Shenli Medical Production Co., Ltd. II May-20-2024
16 LINEAGE BIOMEDICAL, INC III Aug-08-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
18 MEDLINE INDUSTRIES, LP - Northfield II May-31-2024
19 MEDLINE INDUSTRIES, LP - Northfield II May-31-2024
20 MICROVENTION INC. II Nov-04-2021
21 Mckesson Medical-Surgical Inc. Corporate Office II Jun-07-2024
22 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
23 Medtronic MiniMed, Inc. II Apr-21-2025
24 Sol-Millennium Medical Inc. II Sep-06-2024
25 Stradis Healthcare II Jan-11-2023
26 Wolf, Henke Sass, Gmbh II Sep-27-2023
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