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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, antistick
Product CodeMEG
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
GEMTIER MEDICAL (SHANGHAI) INC.
  SUBSTANTIALLY EQUIVALENT 2
HENAN NURSECARE BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JEESUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
RONCADELLE OPERATIONS SRL
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU WEALY MEDICAL INSTRUMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU WEALY MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU SAVICRED BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VAULT PARAGON GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG LINGYANG MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI DR MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 353 353
2021 541 541
2022 174 175
2023 120 120
2024 113 113

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 267 267
Difficult or Delayed Activation 263 263
Break 229 229
Retraction Problem 108 108
Fail-Safe Problem 67 67
Detachment of Device or Device Component 51 52
Device Contaminated During Manufacture or Shipping 47 47
Activation Failure 39 39
Fluid/Blood Leak 38 38
Device Contamination with Chemical or Other Material 38 38
Defective Device 37 37
Activation Problem 34 34
Defective Component 31 31
Material Twisted/Bent 25 25
Failure to Deliver 21 21
Volume Accuracy Problem 19 19
Malposition of Device 16 16
Material Separation 16 16
Device Markings/Labelling Problem 16 16
Material Protrusion/Extrusion 14 14
Positioning Failure 13 13
Material Deformation 13 13
Adverse Event Without Identified Device or Use Problem 9 9
Material Too Soft/Flexible 9 9
Improper or Incorrect Procedure or Method 9 9
Therapeutic or Diagnostic Output Failure 8 8
Packaging Problem 8 8
Mechanical Problem 8 8
Activation, Positioning or Separation Problem 8 8
Fail-Safe Did Not Operate 7 7
Premature Activation 7 7
Component Missing 7 7
Complete Blockage 6 6
Loose or Intermittent Connection 6 6
Contamination /Decontamination Problem 6 6
Use of Device Problem 6 6
Material Puncture/Hole 5 5
Output Problem 5 5
Product Quality Problem 5 5
Dull, Blunt 5 5
Disconnection 5 5
Illegible Information 4 4
Crack 4 4
Tear, Rip or Hole in Device Packaging 4 4
Entrapment of Device 4 4
Separation Problem 4 4
Device Dislodged or Dislocated 3 3
Protective Measures Problem 3 3
Connection Problem 3 3
Delivered as Unsterile Product 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 556 557
Insufficient Information 212 212
No Consequences Or Impact To Patient 148 148
No Known Impact Or Consequence To Patient 130 130
Needle Stick/Puncture 100 100
No Patient Involvement 57 57
Foreign Body In Patient 54 54
Device Embedded In Tissue or Plaque 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Pain 13 13
Chemical Exposure 10 10
Underdose 9 9
Hemorrhage/Bleeding 7 7
Exposure to Body Fluids 5 5
Anxiety 3 3
No Code Available 2 2
Missed Dose 2 2
Fever 2 2
Swelling 2 2
Discomfort 2 2
Unintended Radiation Exposure 2 2
Injection Site Reaction 1 1
No Information 1 1
Blood Loss 1 1
Chest Tightness/Pressure 1 1
Swelling/ Edema 1 1
Infiltration into Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Nov-08-2024
2 Guangdong Haiou Medical Apparatus Co., Ltd II Aug-05-2022
3 Smiths Medical ASD Inc. I Jun-10-2021
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