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 Code	NSC
Regulation Number	880.5860
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	14	15
Failure to Fire	10	10
Mechanical Problem	8	10
Failure to Deliver	8	11
Physical Resistance/Sticking	4	4
Component Missing	4	4
Material Twisted/Bent	4	4
Mechanical Jam	4	4
Break	3	3
Defective Component	3	3
Fluid/Blood Leak	3	5
Leak/Splash	2	2
Activation, Positioning or Separation Problem	2	3
Failure to Eject	2	2
Insufficient Information	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Patient-Device Incompatibility	1	1
Device Fell	1	1
Patient Device Interaction Problem	1	1
Air/Gas in Device	1	1
Key or Button Unresponsive/not Working	1	1
Material Fragmentation	1	1
Misfire	1	1
Use of Device Problem	1	1
Obstruction of Flow	1	1
Gas/Air Leak	1	1
Retraction Problem	1	2
Device Contamination with Chemical or Other Material	1	1
No Apparent Adverse Event	1	1
Missing Information	1	1
Failure to Infuse	1	1
No Flow	1	1
Inadequate User Interface	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	48	52
Insufficient Information	25	26
Anaphylactoid	2	2
Swelling/ Edema	2	2
Skin Inflammation/ Irritation	1	1
Itching Sensation	1	1
Blister	1	1
Cardiac Arrest	1	1
Erythema	1	1
Discomfort	1	1
Pain	1	1
Skin Burning Sensation	1	1