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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 2
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 5
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BIMED TEKNIK ALETLER SANAYI & TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINALHEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARE FUSION
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 2
CMT HEALTH PTE., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
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 2
JIANGSU CAINA MEDICAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
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
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
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 7
PROSIDYAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
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
  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 5334 5373
2021 5874 5901
2022 5233 5240
2023 5214 5220
2024 5122 5138
2025 4246 4246
2026 334 334

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6196 6208
Device Contamination with Chemical or Other Material 3836 3837
Break 3193 3207
Patient Device Interaction Problem 2649 2649
Volume Accuracy Problem 1433 1434
Computer Software Problem 1431 1432
Failure to Deliver 1358 1358
Device Markings/Labelling Problem 1343 1351
Contamination 1000 1005
Defective Component 1000 1002
Material Too Rigid or Stiff 908 908
Physical Resistance/Sticking 705 706
Defective Device 635 642
Packaging Problem 623 623
Crack 583 585
Fluid/Blood Leak 511 523
Connection Problem 451 456
Detachment of Device or Device Component 430 433
Data Problem 407 407
Wireless Communication Problem 395 396
Material Separation 383 383
Contamination /Decontamination Problem 382 386
Material Integrity Problem 368 369
Appropriate Term/Code Not Available 331 333
Inaccurate Delivery 330 330
Mechanical Jam 327 328
Material Deformation 325 326
Insufficient Flow or Under Infusion 306 306
Insufficient Information 292 292
Adverse Event Without Identified Device or Use Problem 286 288
Manufacturing, Packaging or Shipping Problem 240 244
Product Quality Problem 226 228
Delivered as Unsterile Product 210 210
Missing Information 199 199
Complete Blockage 199 199
Material Puncture/Hole 183 183
Improper or Incorrect Procedure or Method 174 174
Failure to Align 173 173
Mechanical Problem 149 150
Off-Label Use 142 142
Battery Problem 129 130
Loose or Intermittent Connection 120 120
Material Twisted/Bent 117 122
Dull, Blunt 101 101
Illegible Information 100 100
Material Protrusion/Extrusion 100 100
Infusion or Flow Problem 86 86
Fracture 80 80
Difficult or Delayed Activation 72 72
Excess Flow or Over-Infusion 69 69

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21806 21843
No Consequences Or Impact To Patient 2332 2332
Hyperglycemia 1943 1944
No Known Impact Or Consequence To Patient 1835 1856
No Patient Involvement 1361 1364
Insufficient Information 1249 1270
Hypoglycemia 428 428
Needle Stick/Puncture 321 322
Diabetic Ketoacidosis 126 126
Foreign Body In Patient 119 119
Pain 115 115
Coma 100 100
Exposure to Body Fluids 60 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 43
Loss of consciousness 34 34
Chemical Exposure 31 31
Nausea 28 28
Hemorrhage/Bleeding 26 26
Fatigue 25 25
Laceration(s) 22 23
Unspecified Infection 21 21
Low Blood Pressure/ Hypotension 21 21
No Code Available 20 20
Bruise/Contusion 19 19
No Information 19 19
Device Embedded In Tissue or Plaque 18 18
Injection Site Reaction 18 18
Vomiting 17 17
Skin Inflammation/ Irritation 16 16
Missed Dose 16 16
Polydipsia 16 16
Hypersensitivity/Allergic reaction 15 15
Fever 15 15
Underdose 14 14
Malaise 13 13
Discomfort 13 13
Dizziness 11 11
Headache 11 11
Eye Injury 10 10
Confusion/ Disorientation 10 10
Bacterial Infection 10 11
Overdose 9 9
Convulsion/Seizure 9 9
Syncope/Fainting 9 9
Abdominal Pain 9 9
Chills 8 8
Visual Impairment 8 8
Injury 8 8
Unspecified Tissue Injury 8 8
Skin Tears 8 9

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