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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
2018 88 88
2019 95 95
2020 157 157
2021 87 87
2022 58 58
2023 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 213 213
Misfire 90 90
Break 31 31
Defective Device 25 25
Physical Resistance/Sticking 17 17
Mechanical Jam 15 15
Defective Component 13 13
Failure to Deliver 13 13
Therapeutic or Diagnostic Output Failure 12 12
Material Twisted/Bent 9 9
Fluid/Blood Leak 9 9
Output Problem 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Leak/Splash 6 6
Mechanical Problem 5 5
Activation, Positioning or Separation Problem 5 5
Device Operates Differently Than Expected 5 5
Insufficient Information 5 5
Patient-Device Incompatibility 4 4
Inaccurate Delivery 4 4
Use of Device Problem 4 4
Device Slipped 3 3
Failure to Infuse 3 3
Dull, Blunt 3 3
Detachment Of Device Component 3 3
Ejection Problem 3 3
Failure to Eject 2 2
Key or Button Unresponsive/not Working 2 2
Improper Flow or Infusion 2 2
Insufficient Flow or Under Infusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Packaging Problem 2 2
Difficult to Remove 2 2
Detachment of Device or Device Component 2 2
Failure to Fire 2 2
Component Missing 1 1
Connection Problem 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Retraction Problem 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Excess Flow or Over-Infusion 1 1
Difficult to Insert 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Disconnection 1 1
Entrapment of Device 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Device Alarm System 1 1
Loss of or Failure to Bond 1 1
No Apparent Adverse Event 1 1
Inadequate User Interface 1 1
Device-Device Incompatibility 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
No Flow 1 1
Activation Problem 1 1
Firing Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 168 168
No Clinical Signs, Symptoms or Conditions 119 119
No Known Impact Or Consequence To Patient 118 118
Insufficient Information 31 31
Missed Dose 15 15
Hyperglycemia 10 10
Pain 9 9
Needle Stick/Puncture 7 7
Underdose 7 7
Swelling 5 5
Reaction, Injection Site 4 4
Bruise/Contusion 3 3
No Information 3 3
Erythema 2 2
Hypersensitivity/Allergic reaction 2 2
Inflammation 2 2
Bacterial Infection 2 2
Anxiety 2 2
Injury 2 2
Itching Sensation 2 2
Local Reaction 2 2
Scar Tissue 1 1
Scarring 1 1
Sepsis 1 1
Seroma 1 1
Skin Irritation 1 1
Necrosis 1 1
Tinnitus 1 1
Burning Sensation 1 1
Arthralgia 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Irritation 1 1
Abdominal Pain 1 1
Abrasion 1 1
High Blood Pressure/ Hypertension 1 1
Hypoglycemia 1 1
Eye Injury 1 1
Fever 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Cataract 1 1
Chest Pain 1 1
Dyspnea 1 1
No Code Available 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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