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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device injector, fluid, non-electrically powered
Product CodeKZE
Regulation Number 880.5430
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Noise, Audible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Crack 1 1
Improper or Incorrect Procedure or Method 1 1
Inaccurate Delivery 1 1
Chemical Spillage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperglycemia 5 5
Diabetic Ketoacidosis 3 3
Hypoglycemia 2 2
Pain 1 1
Skin Irritation 1 1
Vomiting 1 1
Malaise 1 1
Abscess 1 1
Death 1 1
Erythema 1 1
Fall 1 1
Glaucoma 1 1
Loss of consciousness 1 1
Confusion/ Disorientation 1 1
Chemical Exposure 1 1
No Known Impact Or Consequence To Patient 1 1
Test Result 1 1
No Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CaridianBCT, Inc. II May-11-2012
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