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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device injector, pen
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
2014 34 34
2015 55 55
2016 38 38
2017 9 9
2018 16 16
2019 90 90
2020 34 34
2021 22 22
2022 9 9
2023 15 15
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 57 57
Failure to Deliver 43 43
Leak/Splash 23 23
Device Operates Differently Than Expected 16 16
Adverse Event Without Identified Device or Use Problem 16 16
Fluid/Blood Leak 14 14
Insufficient Information 14 14
Misconnection 13 13
Improper or Incorrect Procedure or Method 13 13
Component Missing 13 13
Defective Device 12 12
Mechanical Jam 11 11
Mechanical Problem 10 10
Physical Resistance/Sticking 9 9
Difficult or Delayed Activation 7 7
Failure to Fire 6 6
Sticking 6 6
Use of Device Problem 5 5
Inaccurate Delivery 5 5
Defective Component 5 5
Device Markings/Labelling Problem 5 5
Material Protrusion/Extrusion 4 4
Material Twisted/Bent 4 4
Packaging Problem 4 4
Device Damaged Prior to Use 4 4
Crack 4 4
Poor Quality Image 3 3
Nonstandard Device 3 3
Device Inoperable 3 3
Incorrect Or Inadequate Test Results 3 3
Patient-Device Incompatibility 3 3
Human-Device Interface Problem 3 3
Device Handling Problem 3 3
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Flow 2 2
Inadequate User Interface 2 2
Device Contamination with Chemical or Other Material 2 2
Mechanics Altered 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Activation, Positioning or Separation Problem 2 2
High Test Results 2 2
Insufficient Flow or Under Infusion 2 2
Air Leak 2 2
Device Slipped 2 2
Device Difficult to Setup or Prepare 2 2
Material Puncture/Hole 2 2
Complete Blockage 2 2
Detachment Of Device Component 2 2
Component Falling 2 2
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Material Disintegration 1 1
No Display/Image 1 1
Particulates 1 1
Peeled/Delaminated 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Unable to Obtain Readings 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Failure to Read Input Signal 1 1
Failure to Prime 1 1
Misassembled 1 1
Unexpected Therapeutic Results 1 1
Failure to Advance 1 1
Low Battery 1 1
Failure to Infuse 1 1
Device Displays Incorrect Message 1 1
Battery Problem 1 1
Connection Problem 1 1
No Fail-Safe Mechanism 1 1
Programming Issue 1 1
Gas/Air Leak 1 1
Device Dislodged or Dislocated 1 1
Infusion or Flow Problem 1 1
Improper Flow or Infusion 1 1
Device Fell 1 1
Missing Information 1 1
Air/Gas in Device 1 1
Key or Button Unresponsive/not Working 1 1
No Apparent Adverse Event 1 1
Application Program Problem: Medication Error 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 108 108
Hyperglycemia 71 71
Hypoglycemia 36 36
No Clinical Signs, Symptoms or Conditions 29 29
Insufficient Information 24 24
Pain 18 18
Device Embedded In Tissue or Plaque 11 11
No Patient Involvement 9 9
Diabetic Ketoacidosis 9 9
Needle Stick/Puncture 9 9
Underdose 8 8
No Code Available 8 8
Dizziness 7 7
No Consequences Or Impact To Patient 7 7
Vomiting 6 6
Weakness 5 5
No Information 5 5
Foreign Body In Patient 5 5
Sweating 5 5
Weight Changes 4 4
Numbness 4 4
Complaint, Ill-Defined 4 4
Unspecified Infection 4 4
Fainting 4 4
Itching Sensation 3 3
Anxiety 3 3
Discomfort 3 3
Polydipsia 2 2
Constipation 2 2
Inflammation 2 2
Diarrhea 2 2
Dyspnea 2 2
Erythema 2 2
Nausea 2 2
Neuropathy 2 2
Fall 2 2
Fever 2 2
Abscess 2 2
Cardiac Arrest 2 2
Cataract 2 2
Infarction, Cerebral 2 2
Injury 2 2
Malaise 2 2
Tingling 2 2
Therapeutic Response, Decreased 2 2
Coma 2 2
Visual Impairment 2 2
Anaphylactoid 2 2
Skin Discoloration 2 2
Seizures 2 2
Tissue Damage 2 2
Transient Ischemic Attack 1 1
Urinary Tract Infection 1 1
Sepsis 1 1
Swelling 1 1
Tachycardia 1 1
Thyroid Problems 1 1
Convulsion, Clonic 1 1
Discharge 1 1
Visual Disturbances 1 1
Burning Sensation 1 1
Reaction, Injection Site 1 1
Chest Tightness/Pressure 1 1
Palpitations 1 1
Shaking/Tremors 1 1
Urinary Frequency 1 1
Chills 1 1
Depression 1 1
Chest Pain 1 1
Deafness 1 1
Stroke/CVA 1 1
Arthritis 1 1
Syncope 1 1
Abdominal Pain 1 1
Bone Fracture(s) 1 1
Granuloma 1 1
Head Injury 1 1
Headache 1 1
Hearing Loss 1 1
Hemorrhage/Bleeding 1 1
Reocclusion 1 1
Overdose 1 1
Neonatal Hearing Loss 1 1
Pneumonia 1 1
Rash 1 1
Retinal Detachment 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Memory Loss/Impairment 1 1
Myocardial Infarction 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Missed Dose 1 1
Blood Loss 1 1
Pregnancy 1 1
Fibrosis 1 1
Test Result 1 1

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