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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 PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BERPU 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
GLOBAL MEDI PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HENAN NURSECARE BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INVIRO MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
JEESUNG MEDICAL 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
JIANGSU YILE MEDICAL ARTICLE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDICALCHAIN INTL. CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
NEMERA
  SUBSTANTIALLY EQUIVALENT 1
REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA
  SUBSTANTIALLY EQUIVALENT 1
REXAM HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
REXAM PHARMA
  SUBSTANTIALLY EQUIVALENT 1
RONCADELLE OPERATIONS SRL
  SUBSTANTIALLY EQUIVALENT 1
SAFETY SYRINGES, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
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
SINCERE MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOL-MILLENNIUM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STA-MED, LLC
  SUBSTANTIALLY EQUIVALENT 2
SUNWELL BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU SAVICRED BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
U&U MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ULTI-MED INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTIMED INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
UNILIFE MEDICAL SOLUTIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VAULT PARAGON GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEST PHARMACEUTICAL SERVICES
  SUBSTANTIALLY EQUIVALENT 1
WEST PHARMACEUTICAL SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU MEDLINE INDUSTRY CO., LTD.
  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
2014 36 36
2015 50 50
2016 94 94
2017 181 181
2018 269 269
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 493 493
Difficult or Delayed Activation 351 351
Break 335 335
Retraction Problem 238 238
Fluid/Blood Leak 94 94
Fail-Safe Problem 90 90
Use of Device Problem 77 77
Detachment of Device or Device Component 73 74
Failure to Deliver 67 67
Device Contamination with Chemical or Other Material 65 65
Defective Device 63 63
Activation Problem 50 50
Material Protrusion/Extrusion 48 48
Device Contaminated During Manufacture or Shipping 47 47
Device Operates Differently Than Expected 47 47
Detachment Of Device Component 47 47
Activation Failure 40 40
Device Markings/Labelling Problem 38 38
Volume Accuracy Problem 33 33
Defective Component 32 32
Material Twisted/Bent 30 30
Material Separation 26 26
Bent 22 22
Loose or Intermittent Connection 22 22
Adverse Event Without Identified Device or Use Problem 21 21
Protective Measures Problem 17 17
Component Missing 17 17
Mechanical Problem 16 16
Material Deformation 15 15
Malposition of Device 15 15
Premature Activation 14 14
Positioning Failure 13 13
Crack 12 12
Activation, Positioning or Separation Problem 12 12
Device Dislodged or Dislocated 12 12
Packaging Problem 12 12
Fail-Safe Did Not Operate 11 11
Device Damaged Prior to Use 11 11
Improper or Incorrect Procedure or Method 10 10
Complete Blockage 10 10
Fail-Safe Design Failure 10 10
Material Too Soft/Flexible 10 10
Therapeutic or Diagnostic Output Failure 10 10
Device Or Device Fragments Location Unknown 10 10
Structural Problem 10 10
Component Falling 9 9
Material Puncture/Hole 8 8
Difficult to Remove 7 7
Delivered as Unsterile Product 7 7
Contamination /Decontamination Problem 7 7
Difficult to Open or Close 7 7
Device Fell 7 7
Dull, Blunt 6 6
Entrapment of Device 6 6
Unintended Ejection 5 5
Difficult to Insert 5 5
Disconnection 5 5
Failure to Advance 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Noise, Audible 5 5
Insufficient Information 5 5
Output Problem 5 5
No Fail-Safe Mechanism 4 4
Appropriate Term/Code Not Available 4 4
Physical Resistance/Sticking 4 4
Separation Problem 4 4
Illegible Information 4 4
Misconnection 4 4
Product Quality Problem 4 4
Device Slipped 4 4
Inaccurate Delivery 4 4
Device Issue 4 4
Tear, Rip or Hole in Device Packaging 4 4
Failure to Infuse 3 3
Insufficient Flow or Under Infusion 3 3
Sticking 3 3
Device Inoperable 3 3
Contamination 3 3
Material Fragmentation 3 3
Material Integrity Problem 3 3
Infusion or Flow Problem 3 3
Improper Flow or Infusion 3 3
Difficult to Advance 3 3
Obstruction of Flow 3 3
Connection Problem 3 3
Failure to Fire 2 2
Patient-Device Incompatibility 2 2
Chemical Spillage 2 2
Failure to Align 2 2
Failure to Obtain Sample 2 2
Device Packaging Compromised 2 2
Gas/Air Leak 2 2
Mechanical Jam 2 2
No Flow 2 2
No Pressure 2 2
Inaccurate Information 2 2
Air/Gas in Device 2 2
Explosion 2 2
Application Program Problem: Medication Error 2 2
Migration or Expulsion of Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 840 840
No Clinical Signs, Symptoms or Conditions 500 501
No Consequences Or Impact To Patient 278 278
Insufficient Information 206 206
Needle Stick/Puncture 204 204
No Patient Involvement 97 97
Foreign Body In Patient 62 62
No Information 47 47
Device Embedded In Tissue or Plaque 33 33
Underdose 19 19
Chemical Exposure 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Pain 15 15
Exposure to Body Fluids 15 15
No Code Available 13 13
Hemorrhage/Bleeding 9 9
Missed Dose 6 6
Injury 6 6
Death 5 5
Discomfort 5 5
Swelling 4 4
Anxiety 2 2
Fever 2 2
Blood Loss 2 2
Fluid Discharge 1 1
Reaction 1 1
Reaction, Injection Site 1 1
Swelling/ Edema 1 1
Test Result 1 1
Vitreous Floaters 1 1
Hyperglycemia 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Undesired Nerve Stimulation 1 1
Abrasion 1 1
Tissue Damage 1 1
Visual Impairment 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Jun-21-2013
2 Becton Dickinson & Company III Jan-13-2009
3 Guangdong Haiou Medical Apparatus Co., Ltd II Aug-05-2022
4 Inviro Medical Devices, Inc II Jun-11-2010
5 Smiths Medical ASD Inc. I Jun-10-2021
6 Smiths Medical ASD, Inc. II Jan-08-2014
7 Terumo Medical Corp II Dec-24-2015
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