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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
BIMED TEKNIK ALETLER SANAYI & TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
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
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
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 2146 2146

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5950 5950
Device Contamination with Chemical or Other Material 3764 3764
Break 3095 3095
Patient Device Interaction Problem 2295 2295
Computer Software Problem 1430 1430
Volume Accuracy Problem 1420 1420
Device Markings/Labelling Problem 1334 1337
Failure to Deliver 1303 1303
Defective Component 958 958
Material Too Rigid or Stiff 908 908
Contamination 804 804
Defective Device 609 609
Packaging Problem 598 598
Crack 527 527
Fluid/Blood Leak 488 488
Physical Resistance/Sticking 417 417
Detachment of Device or Device Component 416 416
Material Separation 379 379
Wireless Communication Problem 370 370
Connection Problem 322 322
Appropriate Term/Code Not Available 316 316
Material Deformation 311 311
Mechanical Jam 293 293
Insufficient Information 284 284
Inaccurate Delivery 262 262
Adverse Event Without Identified Device or Use Problem 256 256
Insufficient Flow or Under Infusion 230 230
Contamination /Decontamination Problem 219 219
Product Quality Problem 200 200
Delivered as Unsterile Product 199 199
Complete Blockage 199 199
Missing Information 199 199
Manufacturing, Packaging or Shipping Problem 180 180
Material Puncture/Hole 179 179
Material Integrity Problem 164 164
Failure to Align 148 148
Mechanical Problem 140 140
Improper or Incorrect Procedure or Method 134 134
Battery Problem 117 117
Data Problem 116 116
Off-Label Use 115 115
Loose or Intermittent Connection 106 106
Material Twisted/Bent 102 102
Illegible Information 100 100
Material Protrusion/Extrusion 96 96
Dull, Blunt 94 94
Fracture 78 78
Difficult or Delayed Activation 71 71
Component Missing 65 65
No Flow 60 60

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19810 19813
No Consequences Or Impact To Patient 2332 2332
No Known Impact Or Consequence To Patient 1831 1831
Hyperglycemia 1655 1655
No Patient Involvement 1361 1361
Insufficient Information 1210 1210
Hypoglycemia 357 357
Needle Stick/Puncture 292 292
Diabetic Ketoacidosis 114 114
Foreign Body In Patient 113 113
Pain 108 108
Coma 89 89
Exposure to Body Fluids 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Loss of consciousness 31 31
Chemical Exposure 29 29
Hemorrhage/Bleeding 24 24
Laceration(s) 22 22
Nausea 22 22
Unspecified Infection 21 21
Low Blood Pressure/ Hypotension 20 20
Fatigue 20 20
No Code Available 20 20
No Information 19 19
Device Embedded In Tissue or Plaque 18 18
Bruise/Contusion 18 18
Injection Site Reaction 16 16
Missed Dose 16 16
Fever 15 15
Vomiting 15 15
Hypersensitivity/Allergic reaction 15 15
Underdose 14 14
Skin Inflammation/ Irritation 13 13
Polydipsia 13 13
Discomfort 13 13
Bacterial Infection 10 10
Dizziness 9 9
Headache 9 9
Eye Injury 9 9
Overdose 9 9
Malaise 9 9
High Blood Pressure/ Hypertension 8 8
Injury 8 8
Unspecified Tissue Injury 8 8
Convulsion/Seizure 8 8
Skin Tears 8 8
Chills 8 8
Myocardial Infarction 7 7
Abdominal Pain 7 7
Visual Impairment 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 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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