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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
tube, collection, capillary blood
Product Code
GIO
Regulation Number
864.6150
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2017
1
1
2019
1
1
2020
1
1
2021
2
2
2022
2
2
2023
2
2
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
5
5
Leak/Splash
2
2
Use of Device Problem
2
2
Fitting Problem
1
1
Output Problem
1
1
Material Puncture/Hole
1
1
Complete Blockage
1
1
Material Integrity Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Obstruction of Flow
1
1
Material Too Rigid or Stiff
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6
6
Injury
3
3
No Known Impact Or Consequence To Patient
2
2
Insufficient Information
2
2
Cognitive Changes
1
1
Needle Stick/Puncture
1
1
Dyspnea
1
1
Visual Impairment
1
1
Laceration(s)
1
1
Toxicity
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Radiometer Medical ApS
II
Jun-03-2020
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