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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 88 88
2022 58 58
2023 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 208 208
Misfire 87 87
Break 31 31
Defective Device 26 26
Physical Resistance/Sticking 17 17
Mechanical Jam 16 16
Defective Component 13 13
Failure to Deliver 13 13
Therapeutic or Diagnostic Output Failure 12 12
Fluid/Blood Leak 9 9
Output Problem 8 8
Material Twisted/Bent 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
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
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
Failure to Eject 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 Known Impact Or Consequence To Patient 118 118
No Clinical Signs, Symptoms or Conditions 106 106
Insufficient Information 32 32
Missed Dose 15 15
Hyperglycemia 10 10
Pain 9 9
Underdose 7 7
Needle Stick/Puncture 6 6
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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