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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
2018 16 16
2019 90 90
2020 34 34
2021 22 22
2022 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 36 36
Break 27 27
Leak/Splash 19 19
Misconnection 13 13
Fluid/Blood Leak 11 11
Component Missing 10 10
Defective Device 8 8
Physical Resistance/Sticking 7 7
Mechanical Problem 6 6
Defective Component 5 5
Material Protrusion/Extrusion 4 4
Packaging Problem 4 4
Device Damaged Prior to Use 4 4
Device Markings/Labelling Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Nonstandard Device 3 3
Material Twisted/Bent 3 3
Mechanical Jam 3 3
Patient-Device Incompatibility 2 2
Crack 2 2
Material Puncture/Hole 2 2
Activation, Positioning or Separation Problem 2 2
Inadequate User Interface 2 2
Use of Device Problem 2 2
Inaccurate Delivery 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
No Apparent Adverse Event 1 1
No Fail-Safe Mechanism 1 1
No Flow 1 1
Retraction Problem 1 1
Device Slipped 1 1
Particulates 1 1
Key or Button Unresponsive/not Working 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult or Delayed Positioning 1 1
Misassembled 1 1
High Test Results 1 1
Difficult or Delayed Activation 1 1
Device Displays Incorrect Message 1 1
Gas/Air Leak 1 1
Material Disintegration 1 1
Patient Device Interaction Problem 1 1
Failure to Infuse 1 1
Failure to Advance 1 1
Battery Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Fell 1 1
Failure to Read Input Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 86 86
No Clinical Signs, Symptoms or Conditions 18 18
Insufficient Information 17 17
No Patient Involvement 9 9
Device Embedded In Tissue or Plaque 8 8
Needle Stick/Puncture 7 7
Pain 7 7
No Code Available 5 5
No Consequences Or Impact To Patient 4 4
Abscess 2 2
Underdose 2 2
Foreign Body In Patient 2 2
No Information 2 2
Inflammation 2 2
Discharge 1 1
Missed Dose 1 1
Hyperglycemia 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Swelling/ Edema 1 1
Rash 1 1
Sepsis 1 1
Reaction, Injection Site 1 1
Injury 1 1
Cardiac Arrest 1 1
Granuloma 1 1
Unspecified Infection 1 1
Blood Loss 1 1
Fibrosis 1 1

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