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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
2021 87 91
2022 58 66
2023 35 35
2024 27 27
2025 17 17
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 55 55
Misfire 51 51
Ejection Problem 4 4
Packaging Problem 3 3
Failure to Eject 2 2
Mechanical Jam 2 2
Sharp Edges 2 2
Patient-Device Incompatibility 2 2
Material Twisted/Bent 2 2
Complete Blockage 1 1
Fluid/Blood Leak 1 1
Obstruction of Flow 1 1
Insufficient Device Problem Information 1 1
Difficult to Insert 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 154 157
Insufficient Information 40 45
No Consequences Or Impact To Patient 11 11
Needle Stick/Puncture 6 6
Bruise/Contusion 4 4
Hyperglycemia 4 4
Unspecified Infection 2 2
Hypersensitivity/Allergic reaction 2 4
Pain 2 4
Arthralgia 1 1
Tinnitus 1 1
Sepsis 1 1
Fever 1 1
Abrasion 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Localized Skin Lesion 1 1
Device Embedded In Tissue or Plaque 1 1
Inflammation 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Chest Pain 1 1
Dyspnea 1 1

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