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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device introducer, syringe needle
Regulation Description Syringe needle introducer.
Product CodeKZH
Regulation Number 880.6920
Device Class 2


Premarket Reviews
ManufacturerDecision
EMED TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNTHON HISPANIA S.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 157 157
2021 87 87
2022 58 58
2023 35 35
2024 27 27
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 125 125
Misfire 76 76
Defective Device 20 20
Break 14 14
Mechanical Jam 12 12
Therapeutic or Diagnostic Output Failure 11 11
Physical Resistance/Sticking 10 10
Defective Component 8 8
Failure to Deliver 8 8
Fluid/Blood Leak 7 7
Material Twisted/Bent 5 5
Leak/Splash 4 4
Activation, Positioning or Separation Problem 4 4
Mechanical Problem 4 4
Ejection Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Output Problem 3 3
Failure to Eject 3 3
Insufficient Information 3 3
Failure to Infuse 3 3
Device Slipped 2 2
Key or Button Unresponsive/not Working 2 2
Improper Flow or Infusion 2 2
Insufficient Flow or Under Infusion 2 2
Failure to Fire 2 2
Packaging Problem 2 2
Noise, Audible 1 1
Dull, Blunt 1 1
Loss of or Failure to Bond 1 1
No Flow 1 1
Firing Problem 1 1
Connection Problem 1 1
Unexpected Therapeutic Results 1 1
Inaccurate Delivery 1 1
Material Separation 1 1
Retraction Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Mechanics Altered 1 1
Structural Problem 1 1
Obstruction of Flow 1 1
Component Missing 1 1
Use of Device Problem 1 1
Difficult to Insert 1 1
Patient-Device Incompatibility 1 1
Complete Blockage 1 1
Device Alarm System 1 1
Activation Problem 1 1
Entrapment of Device 1 1
Burst Container or Vessel 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 149 149
No Consequences Or Impact To Patient 93 93
No Known Impact Or Consequence To Patient 46 46
Insufficient Information 38 38
Missed Dose 10 10
Hyperglycemia 5 5
Needle Stick/Puncture 4 4
Pain 3 3
Hypersensitivity/Allergic reaction 2 2
Swelling 2 2
Anxiety 2 2
Abdominal Pain 1 1
High Blood Pressure/ Hypertension 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arthralgia 1 1
Sepsis 1 1
Skin Irritation 1 1
Cataract 1 1
Inflammation 1 1
Abrasion 1 1
Scarring 1 1
Obstruction/Occlusion 1 1
Blood Loss 1 1
Fever 1 1
Irritation 1 1
Seroma 1 1
Injury 1 1
Foreign Body In Patient 1 1
Chest Pain 1 1
Erythema 1 1
Dyspnea 1 1
Eye Injury 1 1
Underdose 1 1
Hemorrhage/Bleeding 1 1
Tinnitus 1 1
Bruise/Contusion 1 1
Device Embedded In Tissue or Plaque 1 1

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