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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 14 14

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
Adverse Event Without Identified Device or Use Problem 5 5
Leak/Splash 5 5
Mechanical Problem 5 5
Activation, Positioning or Separation Problem 5 5
Insufficient Information 4 4
Ejection Problem 3 3
Use of Device Problem 3 3
Inaccurate Delivery 3 3
Failure to Infuse 3 3
Dull, Blunt 3 3
Device Slipped 3 3
Difficult to Remove 2 2
Detachment of Device or Device Component 2 2
Improper Flow or Infusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Fire 2 2
Patient-Device Incompatibility 2 2
Failure to Eject 2 2
Packaging Problem 2 2
Insufficient Flow or Under Infusion 2 2
Key or Button Unresponsive/not Working 2 2
Mechanics Altered 1 1
Naturally Worn 1 1
No Flow 1 1
Firing Problem 1 1
Activation Problem 1 1
Noise, Audible 1 1
No Apparent Adverse Event 1 1
Connection Problem 1 1
Device-Device Incompatibility 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Retraction Problem 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Unexpected Therapeutic Results 1 1
Device Alarm System 1 1
Loss of or Failure to Bond 1 1
Excess Flow or Over-Infusion 1 1
Difficult to Insert 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Disconnection 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 136 136
No Consequences Or Impact To Patient 124 124
No Known Impact Or Consequence To Patient 90 90
Insufficient Information 34 34
Missed Dose 14 14
Pain 8 8
Hyperglycemia 6 6
Underdose 6 6
Needle Stick/Puncture 5 5
Swelling 4 4
Reaction, Injection Site 3 3
Bruise/Contusion 3 3
Erythema 2 2
Hypersensitivity/Allergic reaction 2 2
Inflammation 2 2
Local Reaction 2 2
Bacterial Infection 2 2
Anxiety 2 2
Injury 1 1
Arthralgia 1 1
Obstruction/Occlusion 1 1
Tinnitus 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Scar Tissue 1 1
Scarring 1 1
Sepsis 1 1
Seroma 1 1
Skin Irritation 1 1
Irritation 1 1
Necrosis 1 1
High Blood Pressure/ Hypertension 1 1
Eye Injury 1 1
Hemorrhage/Bleeding 1 1
Abdominal Pain 1 1
Abrasion 1 1
Cataract 1 1
Chest Pain 1 1
Dyspnea 1 1

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