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TPLC - Total Product Life Cycle
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TPLC
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Device
injector, fluid, non-electrically powered
Product Code
KZE
Regulation Number
880.5430
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOJECT MEDICAL TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
BIOJECT, INC.
SUBSTANTIALLY EQUIVALENT
1
D'ANTONIO CONSULTANTS INTERNATIONAL, INC. (DCI)
SUBSTANTIALLY EQUIVALENT
1
PERFACTION, INC.
SUBSTANTIALLY EQUIVALENT
1
PHARMAJET, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
10
10
2019
1
1
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
8
8
Insufficient Information
4
4
Chemical Spillage
1
1
Noise, Audible
1
1
Crack
1
1
Inaccurate Delivery
1
1
Improper or Incorrect Procedure or Method
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hyperglycemia
5
5
Diabetic Ketoacidosis
3
3
Hypoglycemia
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Death
1
1
Skin Irritation
1
1
No Information
1
1
Test Result
1
1
Malaise
1
1
Chemical Exposure
1
1
Confusion/ Disorientation
1
1
No Known Impact Or Consequence To Patient
1
1
Glaucoma
1
1
Vomiting
1
1
Erythema
1
1
Fall
1
1
Pain
1
1
Abscess
1
1
Loss of consciousness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CaridianBCT, Inc.
II
May-11-2012
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