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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
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AVITUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AZUR MEDICAL COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 4
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BIMED TEKNIK ALETLER SANAYI & TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDINALHEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARE FUSION
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 2
CMT HEALTH PTE., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DLP MEDICAL PRODUCTS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
DUOPROSS MEDITECH CORPORATE
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL, CO.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 3
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  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
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
MERIT MEDICAL SYSTEMS, INC.
  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
PERFECT MEDICAL INDUSTRY (VN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
PROSIDYAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
REVITAL HEALTHCARE (EPZ) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 1
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
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 4
SPM MEDICARE PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
2021 5874 5901
2022 5233 5240
2023 5214 5220
2024 5122 5138
2025 4246 4246
2026 682 682

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 3635 3643
Device Contamination with Chemical or Other Material 2987 2988
Break 2731 2739
Patient Device Interaction Problem 2686 2686
Computer Software Problem 1418 1419
Contamination 1068 1073
Device Markings/Labelling Problem 1050 1055
Volume Accuracy Problem 1047 1048
Defective Component 976 977
Failure to Deliver 927 927
Material Too Rigid or Stiff 908 908
Physical Resistance/Sticking 728 729
Crack 563 564
Defective Device 478 480
Connection Problem 460 465
Data Problem 446 446
Fluid/Blood Leak 446 451
Packaging Problem 417 417
Detachment of Device or Device Component 415 418
Material Integrity Problem 404 405
Wireless Communication Problem 397 398
Material Separation 376 376
Contamination /Decontamination Problem 373 375
Appropriate Term/Code Not Available 336 338
Material Deformation 312 313
Inaccurate Delivery 311 311
Insufficient Flow or Under Infusion 310 310
Mechanical Jam 293 294
Insufficient Information 292 292
Adverse Event Without Identified Device or Use Problem 248 250
Manufacturing, Packaging or Shipping Problem 235 239
Product Quality Problem 218 220
Missing Information 197 197
Failure to Align 175 175
Improper or Incorrect Procedure or Method 156 156
Complete Blockage 155 155
Delivered as Unsterile Product 146 146
Material Puncture/Hole 144 144
Off-Label Use 142 142
Battery Problem 132 133
Mechanical Problem 130 131
Loose or Intermittent Connection 113 113
Material Twisted/Bent 102 104
Infusion or Flow Problem 92 92
Dull, Blunt 86 86
Excess Flow or Over-Infusion 71 71
Illegible Information 71 71
Fracture 71 71
Material Protrusion/Extrusion 61 61
Contamination of Device Ingredient or Reagent 58 58

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21931 21959
Hyperglycemia 1805 1805
Insufficient Information 1216 1233
No Consequences Or Impact To Patient 628 628
Hypoglycemia 381 381
Needle Stick/Puncture 264 265
Diabetic Ketoacidosis 119 119
Foreign Body In Patient 102 102
No Patient Involvement 90 90
Coma 89 89
Pain 84 84
Exposure to Body Fluids 38 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 41
Loss of consciousness 29 29
Chemical Exposure 26 26
Nausea 24 24
Fatigue 23 23
Hemorrhage/Bleeding 21 21
Laceration(s) 21 22
Injection Site Reaction 19 19
Unspecified Infection 18 18
Polydipsia 16 16
Skin Inflammation/ Irritation 16 16
Fever 15 15
Vomiting 14 14
Bruise/Contusion 14 14
Malaise 13 13
Discomfort 11 11
Device Embedded In Tissue or Plaque 11 11
Low Blood Pressure/ Hypotension 11 11
Bacterial Infection 10 11
Hypersensitivity/Allergic reaction 10 10
Headache 10 10
Eye Injury 10 10
Syncope/Fainting 9 9
Convulsion/Seizure 8 8
Chills 8 8
Unspecified Tissue Injury 8 8
Abdominal Pain 8 8
Urinary Frequency 8 8
Skin Tears 7 7
Myocardial Infarction 7 7
Dizziness 7 7
Confusion/ Disorientation 6 6
Air Embolism 6 6
Dehydration 6 6
Swelling/ Edema 6 6
Speech Disorder 6 6
Dyspnea 5 5
Skin Infection 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Allison Medical, Inc. II Dec-13-2022
2 Allison Medical, Inc. II Nov-18-2022
3 B. Braun Medical, Inc. II Sep-27-2023
4 BD SWITZERLAND SARL II Jun-12-2025
5 Becton Dickinson & Company II Mar-10-2023
6 Becton Dickinson & Company II Feb-12-2021
7 Cardinal Health 200, LLC I Feb-02-2024
8 Cardinal Health 200, LLC I Oct-26-2023
9 Cardinal Health 200, LLC II Oct-13-2023
10 Cypress Medical Products LLC II Sep-16-2024
11 Cypress Medical Products LLC II Aug-29-2024
12 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
13 Integra LifeSciences Corp. (NeuroSciences) I Jun-20-2025
14 Integra LifeSciences Corp. (NeuroSciences) I Jun-20-2025
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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