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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 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 2
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
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
SANG-A FRONTEC CO., LTD
  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
2019 497 497
2020 353 353
2021 541 541
2022 174 175
2023 120 120
2024 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 431 431
Difficult or Delayed Activation 343 343
Break 254 254
Retraction Problem 132 132
Fail-Safe Problem 71 71
Failure to Deliver 64 64
Defective Device 62 62
Detachment of Device or Device Component 55 56
Device Contamination with Chemical or Other Material 53 53
Device Contaminated During Manufacture or Shipping 47 47
Material Protrusion/Extrusion 45 45
Activation Problem 44 44
Fluid/Blood Leak 43 43
Activation Failure 39 39
Defective Component 32 32
Volume Accuracy Problem 31 31
Device Markings/Labelling Problem 30 30
Material Twisted/Bent 29 29
Material Separation 19 19
Malposition of Device 15 15
Premature Activation 13 13
Material Deformation 13 13
Positioning Failure 13 13
Loose or Intermittent Connection 12 12
Fail-Safe Did Not Operate 11 11
Mechanical Problem 10 10
Device Damaged Prior to Use 10 10
Material Too Soft/Flexible 10 10
Complete Blockage 10 10
Therapeutic or Diagnostic Output Failure 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Activation, Positioning or Separation Problem 9 9
Improper or Incorrect Procedure or Method 9 9
Packaging Problem 8 8
Component Missing 8 8
Protective Measures Problem 7 7
Delivered as Unsterile Product 6 6
Use of Device Problem 6 6
Contamination /Decontamination Problem 6 6
Material Puncture/Hole 6 6
Dull, Blunt 6 6
Device Fell 5 5
Crack 5 5
Output Problem 5 5
Entrapment of Device 5 5
Disconnection 5 5
Illegible Information 4 4
Insufficient Information 4 4
Device Dislodged or Dislocated 4 4
Tear, Rip or Hole in Device Packaging 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 537 537
No Clinical Signs, Symptoms or Conditions 522 523
Insufficient Information 208 208
No Consequences Or Impact To Patient 161 161
Needle Stick/Puncture 107 107
No Patient Involvement 74 74
Foreign Body In Patient 60 60
Device Embedded In Tissue or Plaque 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
No Information 15 15
Pain 14 14
Underdose 14 14
Chemical Exposure 12 12
Hemorrhage/Bleeding 9 9
No Code Available 6 6
Missed Dose 6 6
Exposure to Body Fluids 5 5
Swelling 4 4
Discomfort 4 4
Fever 2 2
Injury 2 2
Anxiety 2 2
Injection Site Reaction 1 1
Chest Tightness/Pressure 1 1
Blood Loss 1 1
Burning Sensation 1 1
Visual Impairment 1 1
Swelling/ Edema 1 1
Infiltration into Tissue 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Guangdong Haiou Medical Apparatus Co., Ltd II Aug-05-2022
2 Smiths Medical ASD Inc. I Jun-10-2021
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