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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 3
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIMED TEKNIK ALETLER SANAYI & TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS LLC
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  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
ELCAM MEDICAL ACAL
  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 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 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 5239
2023 5214 5215
2024 5122 5122
2025 3593 3593

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6083 6090
Device Contamination with Chemical or Other Material 3818 3819
Break 3152 3164
Patient Device Interaction Problem 2486 2486
Computer Software Problem 1431 1431
Volume Accuracy Problem 1430 1430
Device Markings/Labelling Problem 1342 1349
Failure to Deliver 1325 1325
Defective Component 998 999
Contamination 936 938
Material Too Rigid or Stiff 908 908
Defective Device 634 641
Packaging Problem 609 609
Physical Resistance/Sticking 592 593
Crack 566 568
Fluid/Blood Leak 505 517
Detachment of Device or Device Component 425 428
Connection Problem 395 396
Wireless Communication Problem 386 386
Material Separation 380 380
Appropriate Term/Code Not Available 326 326
Contamination /Decontamination Problem 323 327
Material Deformation 320 321
Mechanical Jam 309 310
Inaccurate Delivery 300 300
Insufficient Information 287 287
Material Integrity Problem 283 283
Data Problem 279 279
Insufficient Flow or Under Infusion 277 277
Adverse Event Without Identified Device or Use Problem 269 270
Manufacturing, Packaging or Shipping Problem 230 234
Delivered as Unsterile Product 209 209
Product Quality Problem 209 211
Missing Information 199 199
Complete Blockage 199 199
Material Puncture/Hole 181 181
Failure to Align 163 163
Improper or Incorrect Procedure or Method 161 161
Mechanical Problem 142 143
Off-Label Use 133 133
Battery Problem 119 119
Material Twisted/Bent 113 118
Loose or Intermittent Connection 112 112
Illegible Information 100 100
Material Protrusion/Extrusion 98 98
Dull, Blunt 98 98
Fracture 80 80
Difficult or Delayed Activation 71 71
Component Missing 67 75
Infusion or Flow Problem 66 66

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21011 21032
No Consequences Or Impact To Patient 2332 2332
No Known Impact Or Consequence To Patient 1835 1856
Hyperglycemia 1810 1811
No Patient Involvement 1361 1364
Insufficient Information 1240 1260
Hypoglycemia 397 397
Needle Stick/Puncture 307 308
Diabetic Ketoacidosis 119 119
Foreign Body In Patient 116 116
Pain 112 112
Coma 95 95
Exposure to Body Fluids 60 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 40
Loss of consciousness 33 33
Chemical Exposure 30 30
Hemorrhage/Bleeding 25 25
Nausea 25 25
Fatigue 23 23
Laceration(s) 22 22
Unspecified Infection 21 21
Low Blood Pressure/ Hypotension 20 20
No Code Available 20 20
No Information 19 19
Bruise/Contusion 18 18
Device Embedded In Tissue or Plaque 18 18
Injection Site Reaction 17 17
Missed Dose 16 16
Vomiting 16 16
Skin Inflammation/ Irritation 15 15
Fever 15 15
Hypersensitivity/Allergic reaction 15 15
Polydipsia 15 15
Underdose 14 14
Discomfort 13 13
Malaise 12 12
Headache 11 11
Bacterial Infection 10 10
Dizziness 10 10
Confusion/ Disorientation 9 9
Overdose 9 9
Eye Injury 9 9
Abdominal Pain 9 9
Chills 8 8
Injury 8 8
Visual Impairment 8 8
Convulsion/Seizure 8 8
Skin Tears 8 9
Unspecified Tissue Injury 8 8
High Blood Pressure/ Hypertension 8 8

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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