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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
Product CodeKZH
Regulation Number 880.6920
Device Class 2


Premarket Reviews
ManufacturerDecision
EMED TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 95 95
2020 157 157
2021 87 87
2022 58 58
2023 35 35
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 157 157
Misfire 84 84
Break 27 27
Defective Device 24 24
Physical Resistance/Sticking 17 17
Mechanical Jam 13 13
Failure to Deliver 13 13
Therapeutic or Diagnostic Output Failure 12 12
Defective Component 11 11
Fluid/Blood Leak 9 9
Material Twisted/Bent 9 9
Output Problem 8 8
Leak/Splash 5 5
Activation, Positioning or Separation Problem 5 5
Mechanical Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 4 4
Inaccurate Delivery 3 3
Failure to Infuse 3 3
Use of Device Problem 3 3
Dull, Blunt 3 3
Device Slipped 3 3
Ejection Problem 3 3
Failure to Fire 2 2
Detachment of Device or Device Component 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Eject 2 2
Patient-Device Incompatibility 2 2
Difficult to Remove 2 2
Key or Button Unresponsive/not Working 2 2
Packaging Problem 2 2
Insufficient Flow or Under Infusion 2 2
Improper Flow or Infusion 2 2
Use of Incorrect Control/Treatment Settings 1 1
Firing Problem 1 1
Structural Problem 1 1
Complete Blockage 1 1
Mechanics Altered 1 1
Excess Flow or Over-Infusion 1 1
Activation Problem 1 1
Entrapment of Device 1 1
Burst Container or Vessel 1 1
Device Alarm System 1 1
Crack 1 1
Disconnection 1 1
Device-Device Incompatibility 1 1
Shipping Damage or Problem 1 1
Obstruction of Flow 1 1
Difficult to Insert 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 140 140
No Consequences Or Impact To Patient 124 124
No Known Impact Or Consequence To Patient 90 90
Insufficient Information 36 36
Missed Dose 14 14
Pain 8 8
Underdose 6 6
Hyperglycemia 6 6
Needle Stick/Puncture 5 5
Swelling 4 4
Bruise/Contusion 3 3
Reaction, Injection Site 3 3
Hypersensitivity/Allergic reaction 2 2
Bacterial Infection 2 2
Anxiety 2 2
Inflammation 2 2
Local Reaction 2 2
Erythema 2 2
Device Embedded In Tissue or Plaque 1 1
Hemorrhage/Bleeding 1 1
Tinnitus 1 1
Eye Injury 1 1
Dyspnea 1 1
Scar Tissue 1 1
Chest Pain 1 1
Irritation 1 1
Seroma 1 1
Injury 1 1
Foreign Body In Patient 1 1
Abrasion 1 1
Scarring 1 1
Obstruction/Occlusion 1 1
Blood Loss 1 1
Cataract 1 1
Necrosis 1 1
Sepsis 1 1
Skin Irritation 1 1
No Code Available 1 1
Arthralgia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Abdominal Pain 1 1
High Blood Pressure/ Hypertension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Owen Mumford USA, Inc. II Nov-01-2019
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