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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device injector, pen
Regulation Description Piston syringe.
Definition A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.
Product CodeNSC
Regulation Number 880.5860
Device Class 2

MDR Year MDR Reports MDR Events
2016 38 38
2017 9 9
2018 16 16
2019 90 90
2020 34 34
2021 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Break 37 37
Failure to Deliver 35 35
Leak/Splash 21 21
Misconnection 13 13
Component Missing 10 10
Fluid Leak 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Physical Resistance/Sticking 7 7
Mechanical Problem 6 6
Defective Device 6 6
Insufficient Information 6 6
Device Operates Differently Than Expected 5 5
Device Markings/Labelling Problem 5 5
Device Damaged Prior to Use 4 4
Defective Component 4 4
Crack 4 4
Packaging Problem 4 4
Material Protrusion/Extrusion 4 4
Material Twisted/Bent 3 3
Mechanical Jam 3 3
Device Handling Problem 3 3
Nonstandard Device 3 3
Inaccurate Delivery 3 3
Difficult or Delayed Activation 3 3
Poor Quality Image 2 2
Sticking 2 2
Device Inoperable 2 2
Improper or Incorrect Procedure or Method 2 2
Material Puncture/Hole 2 2
Device Slipped 2 2
Use of Device Problem 2 2
Device Dislodged or Dislocated 1 1
Inadequate User Interface 1 1
Patient-Device Incompatibility 1 1
Particulates 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Disintegration 1 1
No Display/Image 1 1
Material Split, Cut or Torn 1 1
No Fail-Safe Mechanism 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanics Altered 1 1
Peeled/Delaminated 1 1
Failure to Read Input Signal 1 1
Misassembled 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Difficult or Delayed Positioning 1 1
Device Displays Incorrect Message 1 1
Battery Problem 1 1
Connection Problem 1 1
Failure to Infuse 1 1
High Test Results 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 98 98
Hyperglycemia 17 17
Hypoglycemia 14 14
Device Embedded In Tissue or Plaque 11 11
Pain 10 10
Insufficient Information 10 10
Needle Stick/Puncture 9 9
No Patient Involvement 9 9
No Clinical Signs, Symptoms or Conditions 8 8
No Consequences Or Impact To Patient 7 7
No Code Available 6 6
No Information 3 3
Weakness 3 3
Discomfort 3 3
Complaint, Ill-Defined 3 3
Unspecified Infection 3 3
Numbness 3 3
Sweating 3 3
Underdose 2 2
Fever 2 2
Abscess 2 2
Cataract 2 2
Inflammation 2 2
Infarction, Cerebral 2 2
Diarrhea 2 2
Tingling 2 2
Dizziness 2 2
Tissue Damage 2 2
Foreign Body In Patient 2 2
Vomiting 2 2
Diabetic Ketoacidosis 2 2
Constipation 2 2
Swelling/ Edema 1 1
Fibrosis 1 1
Chest Tightness/Pressure 1 1
Blood Loss 1 1
Weight Changes 1 1
Urinary Tract Infection 1 1
Injury 1 1
Depression 1 1
Bone Fracture(s) 1 1
Granuloma 1 1
Head Injury 1 1
Hemorrhage/Bleeding 1 1
Deafness 1 1
Syncope 1 1
Cardiac Arrest 1 1
Overdose 1 1
Pneumonia 1 1
Retinal Detachment 1 1
Seizures 1 1
Memory Loss/Impairment 1 1
Neonatal Hearing Loss 1 1
Rash 1 1
Sepsis 1 1
Swelling 1 1
Transient Ischemic Attack 1 1
Fall 1 1
Arthritis 1 1
High Blood Pressure/ Hypertension 1 1
Discharge 1 1
Missed Dose 1 1
Coma 1 1
Reaction, Injection Site 1 1

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