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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 173 174
2023 120 120
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 429 429
Difficult or Delayed Activation 343 343
Break 254 254
Retraction Problem 124 124
Fail-Safe Problem 71 71
Failure to Deliver 64 64
Defective Device 61 61
Detachment of Device or Device Component 52 53
Device Contamination with Chemical or Other Material 52 52
Device Contaminated During Manufacture or Shipping 47 47
Material Protrusion/Extrusion 45 45
Activation Problem 44 44
Fluid/Blood Leak 41 41
Activation Failure 39 39
Volume Accuracy Problem 31 31
Device Markings/Labelling Problem 30 30
Defective Component 29 29
Material Twisted/Bent 28 28
Material Separation 19 19
Malposition of Device 14 14
Premature Activation 13 13
Positioning Failure 13 13
Material Deformation 13 13
Fail-Safe Did Not Operate 11 11
Loose or Intermittent Connection 11 11
Mechanical Problem 10 10
Complete Blockage 10 10
Device Damaged Prior to Use 10 10
Material Too Soft/Flexible 10 10
Therapeutic or Diagnostic Output Failure 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Improper or Incorrect Procedure or Method 9 9
Activation, Positioning or Separation Problem 9 9
Component Missing 8 8
Packaging Problem 8 8
Protective Measures Problem 6 6
Use of Device Problem 6 6
Contamination /Decontamination Problem 6 6
Material Puncture/Hole 6 6
Delivered as Unsterile Product 6 6
Disconnection 5 5
Crack 5 5
Dull, Blunt 5 5
Output Problem 5 5
Device Fell 5 5
Illegible Information 4 4
Device Dislodged or Dislocated 4 4
Separation Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Entrapment of Device 4 4
Product Quality Problem 4 4
Misconnection 4 4
Difficult to Insert 3 3
Inaccurate Delivery 3 3
Structural Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Improper Flow or Infusion 3 3
Difficult to Advance 2 2
Difficult to Open or Close 2 2
No Pressure 2 2
Material Integrity Problem 2 2
Mechanical Jam 2 2
No Fail-Safe Mechanism 2 2
Physical Resistance/Sticking 2 2
Explosion 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Inaccurate Information 2 2
Air/Gas in Device 2 2
Failure to Align 2 2
Failure to Advance 2 2
Failure to Obtain Sample 2 2
Failure to Infuse 2 2
Microbial Contamination of Device 2 2
Insufficient Flow or Under Infusion 2 2
Fitting Problem 2 2
Failure to Fire 2 2
Obstruction of Flow 2 2
Difficult to Remove 2 2
Collapse 2 2
Contamination 2 2
Partial Blockage 2 2
Backflow 1 1
Burst Container or Vessel 1 1
Corroded 1 1
Unintended Ejection 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Fragmentation 1 1
Decoupling 1 1
Difficult or Delayed Positioning 1 1
Display Difficult to Read 1 1
Therapy Delivered to Incorrect Body Area 1 1
Short Fill 1 1
Material Too Rigid or Stiff 1 1
Device Difficult to Setup or Prepare 1 1
Misassembled 1 1
Failure to Cut 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1

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 500 501
Insufficient Information 206 206
No Consequences Or Impact To Patient 161 161
Needle Stick/Puncture 104 104
No Patient Involvement 74 74
Foreign Body In Patient 55 55
Device Embedded In Tissue or Plaque 16 16
No Information 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Underdose 14 14
Chemical Exposure 12 12
Pain 12 12
Hemorrhage/Bleeding 8 8
Missed Dose 6 6
No Code Available 6 6
Exposure to Body Fluids 5 5
Swelling 4 4
Discomfort 4 4
Injury 2 2
Anxiety 2 2
Fever 2 2
Infiltration into Tissue 1 1
Visual Impairment 1 1
Burning Sensation 1 1
Blood Loss 1 1
Swelling/ Edema 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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