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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
collector, urine, pediatric, for indwelling catheter
Product Code
FFH
Regulation Number
876.5250
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
4
4
2020
2
2
2021
1
1
2022
5
5
2023
12
12
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Fragmentation
5
5
Disconnection
4
4
Component Missing
4
4
Fitting Problem
3
3
Difficult to Remove
2
2
Component Misassembled
2
2
Difficult to Open or Remove Packaging Material
1
1
Device Damaged Prior to Use
1
1
Short Fill
1
1
Defective Device
1
1
Material Twisted/Bent
1
1
Inaccurate Flow Rate
1
1
Moisture or Humidity Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Loose or Intermittent Connection
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
17
17
No Known Impact Or Consequence To Patient
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Foreign Body In Patient
2
2
No Patient Involvement
2
2
Insufficient Information
2
2
Patient Problem/Medical Problem
1
1
No Consequences Or Impact To Patient
1
1
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