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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
  1.  K243232  GripMate

MDR Year MDR Reports MDR Events
2020 158 164
2021 87 91
2022 58 66
2023 35 35
2024 27 27
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 125 125
Misfire 76 76
Defective Device 22 24
Break 15 16
Mechanical Jam 12 14
Therapeutic or Diagnostic Output Failure 11 15
Physical Resistance/Sticking 10 10
Failure to Deliver 9 9
Defective Component 8 8
Fluid/Blood Leak 7 7
Material Twisted/Bent 5 7
Leak/Splash 4 4
Activation, Positioning or Separation Problem 4 7
Failure to Infuse 4 5
Adverse Event Without Identified Device or Use Problem 4 4
Mechanical Problem 4 5
Ejection Problem 4 4
Insufficient Information 3 3
Patient-Device Incompatibility 3 5
Failure to Eject 3 3
Output Problem 3 3
Key or Button Unresponsive/not Working 2 2
Use of Device Problem 2 2
Improper Flow or Infusion 2 2
Insufficient Flow or Under Infusion 2 3
Packaging Problem 2 2
Failure to Fire 2 2
Device Slipped 2 3
Unintended Movement 1 1
Difficult to Remove 1 1
Complete Blockage 1 1
Device Alarm System 1 1
Difficult to Insert 1 1
Activation Problem 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Mechanics Altered 1 1
Entrapment of Device 1 1
Use of Incorrect Control/Treatment Settings 1 1
Retraction Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Inaccurate Delivery 1 1
Burst Container or Vessel 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Unexpected Therapeutic Results 1 1
Connection Problem 1 1
Firing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 153 156
No Consequences Or Impact To Patient 93 93
No Known Impact Or Consequence To Patient 46 51
Insufficient Information 41 46
Missed Dose 10 11
Hyperglycemia 5 5
Needle Stick/Puncture 4 4
Pain 3 5
Bruise/Contusion 3 3
Unspecified Infection 2 2
Hypersensitivity/Allergic reaction 2 4
Swelling 2 2
Anxiety 2 2
Hemorrhage/Bleeding 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
Discomfort 1 1
Dyspnea 1 1
Eye Injury 1 1
Underdose 1 1
Tinnitus 1 1
Device Embedded In Tissue or Plaque 1 1

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