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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, antistick
Regulation Description Piston syringe.
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
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 541 634
2022 170 185
2023 120 120
2024 112 112
2025 132 132

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 276 278
Difficult or Delayed Activation 263 263
Break 241 262
Retraction Problem 121 151
Fail-Safe Problem 67 81
Detachment of Device or Device Component 57 78
Device Contaminated During Manufacture or Shipping 47 47
Activation Failure 47 47
Fluid/Blood Leak 45 63
Defective Component 42 42
Activation Problem 42 42
Device Contamination with Chemical or Other Material 39 39
Defective Device 37 41
Material Twisted/Bent 26 57
Failure to Deliver 22 22
Volume Accuracy Problem 19 19
Malposition of Device 17 17
Material Separation 17 34
Device Markings/Labelling Problem 16 16
Premature Activation 15 15
Material Protrusion/Extrusion 14 15
Material Deformation 13 13
Positioning Failure 13 13
Contamination 12 12
Decoupling 12 12
Mechanical Problem 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Material Too Soft/Flexible 9 9
Complete Blockage 9 9
Improper or Incorrect Procedure or Method 9 9
Therapeutic or Diagnostic Output Failure 9 9
Component Missing 8 8
Crack 8 8
Loose or Intermittent Connection 8 8
Fail-Safe Did Not Operate 8 8
Packaging Problem 8 8
Activation, Positioning or Separation Problem 8 11
Contamination /Decontamination Problem 7 22
Use of Device Problem 6 6
Output Problem 6 6
Product Quality Problem 5 5
Material Puncture/Hole 5 5
Entrapment of Device 5 6
Dull, Blunt 5 5
Disconnection 5 33
Illegible Information 4 4
Tear, Rip or Hole in Device Packaging 4 4
Protective Measures Problem 4 4
Difficult to Fold, Unfold or Collapse 4 4
Separation Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 662 719
Insufficient Information 212 246
No Consequences Or Impact To Patient 148 148
No Known Impact Or Consequence To Patient 130 130
Needle Stick/Puncture 115 115
No Patient Involvement 57 57
Foreign Body In Patient 53 53
Device Embedded In Tissue or Plaque 18 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 27
Pain 14 14
Chemical Exposure 12 12
Underdose 9 9
Hemorrhage/Bleeding 7 11
Exposure to Body Fluids 5 5
Anxiety 3 3
Unintended Radiation Exposure 3 3
No Code Available 2 2
Missed Dose 2 2
Fever 2 2
Swelling 2 2
Discomfort 2 2
Injection Site Reaction 1 1
No Information 1 1
Chest Tightness/Pressure 1 1
Blood Loss 1 1
Visual Impairment 1 1
Swelling/ Edema 1 1
Infiltration into Tissue 1 1
Loss of Vision 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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