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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
SYNTHON HISPANIA S.L.
  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 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 158 158
Misfire 84 84
Break 27 27
Defective Device 24 24
Physical Resistance/Sticking 17 17
Mechanical Jam 14 14
Failure to Deliver 13 13
Therapeutic or Diagnostic Output Failure 12 12
Defective Component 11 11
Material Twisted/Bent 9 9
Fluid/Blood Leak 9 9
Output Problem 8 8
Mechanical Problem 5 5
Leak/Splash 5 5
Activation, Positioning or Separation Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 4 4
Ejection Problem 4 4
Dull, Blunt 3 3
Device Slipped 3 3
Use of Device Problem 3 3
Failure to Infuse 3 3
Inaccurate Delivery 3 3
Failure to Eject 2 2
Patient-Device Incompatibility 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Remove 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
Detachment of Device or Device Component 2 2
No Flow 1 1
Improper or Incorrect Procedure or Method 1 1
Firing Problem 1 1
Loss of or Failure to Bond 1 1
Unexpected Therapeutic Results 1 1
Connection Problem 1 1
Noise, Audible 1 1
Naturally Worn 1 1
Retraction Problem 1 1
Material Separation 1 1
No Apparent Adverse Event 1 1
Use of Incorrect Control/Treatment Settings 1 1
Mechanics Altered 1 1
Structural Problem 1 1
Excess Flow or Over-Infusion 1 1
Obstruction of Flow 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147 147
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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