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TPLC
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show TPLC since
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2024
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Device
injector, contrast medium, automatic
Product Code
IZQ
Regulation Number
870.1650
Device Class
2
Premarket Reviews
Manufacturer
Decision
BRACCO INJENEERING
SUBSTANTIALLY EQUIVALENT
1
LIEBEL-FLARSHEIM COMPANY LLC
SUBSTANTIALLY EQUIVALENT
1
ULRICH GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2016
7
7
2017
3
3
2018
7
7
2019
9
9
2020
13
13
2021
14
14
2022
24
24
2023
16
16
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
17
17
Improper Flow or Infusion
8
8
No Apparent Adverse Event
6
6
Break
5
5
Insufficient Information
4
4
Detachment of Device or Device Component
3
3
Air/Gas in Device
3
3
Mechanical Problem
3
3
No Display/Image
2
2
Self-Activation or Keying
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Excess Flow or Over-Infusion
2
2
Leak/Splash
2
2
Device Displays Incorrect Message
2
2
Communication or Transmission Problem
2
2
Connection Problem
2
2
Gas/Air Leak
2
2
Device Operates Differently Than Expected
2
2
Device Dislodged or Dislocated
1
1
Extrusion
1
1
Appropriate Term/Code Not Available
1
1
Patient Device Interaction Problem
1
1
Explosion
1
1
Unintended Electrical Shock
1
1
Operating System Becomes Nonfunctional
1
1
Output Problem
1
1
Physical Property Issue
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unintended Movement
1
1
Material Integrity Problem
1
1
No Flow
1
1
Activation, Positioning or Separation Problem
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Bent
1
1
Backflow
1
1
Fitting Problem
1
1
Defective Component
1
1
Component Missing
1
1
Inaccurate Delivery
1
1
Difficult or Delayed Activation
1
1
Defective Device
1
1
Display or Visual Feedback Problem
1
1
False Reading From Device Non-Compliance
1
1
Filling Problem
1
1
Unintended Ejection
1
1
Fluid/Blood Leak
1
1
Burst Container or Vessel
1
1
Complete Blockage
1
1
Computer Software Problem
1
1
Energy Output Problem
1
1
Increase in Pressure
1
1
Device Difficult to Program or Calibrate
1
1
Pumping Stopped
1
1
Difficult to Remove
1
1
Retraction Problem
1
1
Material Rupture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
28
28
No Known Impact Or Consequence To Patient
12
12
Extravasation
10
10
Air Embolism
9
9
Insufficient Information
9
9
Pain
6
6
No Consequences Or Impact To Patient
5
5
Infiltration into Tissue
5
5
Overdose
2
2
No Code Available
2
2
Pulmonary Embolism
1
1
Respiratory Distress
1
1
Distress
1
1
Complaint, Ill-Defined
1
1
Injury
1
1
Needle Stick/Puncture
1
1
Electric Shock
1
1
No Patient Involvement
1
1
Inflammation
1
1
Eye Injury
1
1
Low Blood Pressure/ Hypotension
1
1
Exposure to Body Fluids
1
1
Cardiac Arrest
1
1
Chest Pain
1
1
Death
1
1
Dyspnea
1
1
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