Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Break 57 57
Failure to Deliver 44 44
Leak/Splash 23 23
Adverse Event Without Identified Device or Use Problem 16 16
Device Operates Differently Than Expected 16 16
Defective Device 16 16
Component Missing 16 16
Insufficient Information 14 14
Fluid/Blood Leak 14 14
Improper or Incorrect Procedure or Method 13 13
Misconnection 13 13
Mechanical Jam 11 11
Failure to Fire 10 10
Mechanical Problem 10 10
Physical Resistance/Sticking 9 9
Material Twisted/Bent 7 7
Difficult or Delayed Activation 7 7
Sticking 6 6
Use of Device Problem 6 6
Defective Component 6 6
Device Markings/Labelling Problem 5 5
Inaccurate Delivery 5 5
Device Damaged Prior to Use 4 4
Crack 4 4
Packaging Problem 4 4
Material Protrusion/Extrusion 4 4
Poor Quality Image 3 3
Patient-Device Incompatibility 3 3
Device Handling Problem 3 3
Human-Device Interface Problem 3 3
Nonstandard Device 3 3
Device Inoperable 3 3
Incorrect Or Inadequate Test Results 3 3
Activation, Positioning or Separation Problem 2 2
Material Puncture/Hole 2 2
Complete Blockage 2 2
Device Slipped 2 2
Device Difficult to Setup or Prepare 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Falling 2 2
Detachment Of Device Component 2 2
Inadequate User Interface 2 2
Device Contamination with Chemical or Other Material 2 2
Appropriate Term/Code Not Available 2 2
High Test Results 2 2
Insufficient Flow or Under Infusion 2 2
Mechanics Altered 2 2
No Flow 2 2
Air Leak 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 108 108
Hyperglycemia 71 71
No Clinical Signs, Symptoms or Conditions 45 45
Hypoglycemia 36 36
Insufficient Information 24 24
Pain 19 19
Device Embedded In Tissue or Plaque 11 11
No Patient Involvement 9 9
Diabetic Ketoacidosis 9 9
Needle Stick/Puncture 9 9
No Code Available 8 8
Underdose 8 8
No Consequences Or Impact To Patient 7 7
Dizziness 7 7
Vomiting 6 6
Sweating 5 5
No Information 5 5
Foreign Body In Patient 5 5
Weakness 5 5
Weight Changes 4 4
Unspecified Infection 4 4
Complaint, Ill-Defined 4 4
Numbness 4 4
Fainting 4 4
Discomfort 3 3
Itching Sensation 3 3
Anxiety 3 3
Fall 2 2
Dyspnea 2 2
Visual Impairment 2 2
Diarrhea 2 2
Coma 2 2
Erythema 2 2
Fever 2 2
Injury 2 2
Abscess 2 2
Polydipsia 2 2
Cardiac Arrest 2 2
Skin Discoloration 2 2
Anaphylactoid 2 2
Therapeutic Response, Decreased 2 2
Tissue Damage 2 2
Inflammation 2 2
Malaise 2 2
Constipation 2 2
Cataract 2 2
Seizures 2 2
Nausea 2 2
Infarction, Cerebral 2 2
Tingling 2 2

-
-