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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 5 5

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
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
Inaccurate Delivery 3 3
Device Slipped 3 3
Ejection Problem 3 3
Dull, Blunt 3 3
Failure to Infuse 3 3
Use of Device Problem 3 3
Failure to Eject 2 2
Key or Button Unresponsive/not Working 2 2
Difficult to Remove 2 2
Patient-Device Incompatibility 2 2
Failure to Fire 2 2
Insufficient Flow or Under Infusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Improper Flow or Infusion 2 2
Packaging Problem 2 2
Detachment of Device or Device Component 2 2
Noise, Audible 1 1
Crack 1 1
Naturally Worn 1 1
Entrapment of Device 1 1
Difficult to Insert 1 1
Device Alarm System 1 1
Mechanics Altered 1 1
Firing Problem 1 1
Disconnection 1 1
Device-Device Incompatibility 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Separation 1 1
Excess Flow or Over-Infusion 1 1
Complete Blockage 1 1
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1
Burst Container or Vessel 1 1
Connection Problem 1 1
Loss of or Failure to Bond 1 1
Retraction Problem 1 1
Component Missing 1 1
No Flow 1 1
No Apparent Adverse Event 1 1
Activation Problem 1 1
Structural Problem 1 1
Obstruction of Flow 1 1
Shipping Damage or Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 128 128
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 4 4
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
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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