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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
YPSOMED AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 88 88
2018 88 88
2019 95 95
2020 157 157
2021 88 88
2022 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 254 254
Misfire 106 106
Break 30 30
Defective Device 25 25
Physical Resistance/Sticking 16 16
Mechanical Jam 15 15
Defective Component 13 13
Failure to Deliver 13 13
Therapeutic or Diagnostic Output Failure 12 12
Material Twisted/Bent 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Output Problem 8 8
Device Operates Differently Than Expected 8 8
Fluid/Blood Leak 8 8
Insufficient Information 7 7
Leak/Splash 6 6
Mechanical Problem 5 5
Activation, Positioning or Separation Problem 5 5
Patient-Device Incompatibility 4 4
Inaccurate Delivery 4 4
Use of Device Problem 4 4
Detachment Of Device Component 4 4
Bent 3 3
Device Slipped 3 3
Failure to Infuse 3 3
Dull, Blunt 3 3
Component Missing 3 3
Ejection Problem 3 3
Improper Flow or Infusion 2 2
Failure to Fire 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Detachment of Device or Device Component 2 2
Improper or Incorrect Procedure or Method 2 2
Difficult to Remove 2 2
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
Loss of or Failure to Bond 1 1
Burst Container or Vessel 1 1
Component Falling 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Disconnection 1 1
Entrapment of Device 1 1
Insufficient Flow or Under Infusion 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Structural Problem 1 1
Connection Problem 1 1
Device Displays Incorrect Message 1 1
Inadequate User Interface 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1
Device-Device Incompatibility 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
No Flow 1 1
Failure to Eject 1 1
Firing Problem 1 1
Activation Problem 1 1
Key or Button Unresponsive/not Working 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 233 233
No Known Impact Or Consequence To Patient 130 130
No Clinical Signs, Symptoms or Conditions 93 93
Insufficient Information 28 28
Hyperglycemia 16 16
Missed Dose 15 15
Pain 9 9
Underdose 7 7
Needle Stick/Puncture 6 6
Swelling 5 5
No Information 5 5
Reaction, Injection Site 4 4
Bruise/Contusion 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
No Patient Involvement 2 2
Foreign Body In Patient 1 1
Blood Loss 1 1
No Code Available 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
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
Diabetic Ketoacidosis 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

Recalls
Manufacturer Recall Class Date Posted
1 International Medsurg Connection, Inc. II Aug-04-2017
2 Owen Mumford USA, Inc. II Nov-01-2019
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