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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
2018
14
14
2019
4
4
2020
2
2
2021
1
1
2022
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Component Missing
6
6
Inaccurate Flow Rate
4
4
Leak/Splash
2
2
Improper or Incorrect Procedure or Method
2
2
Material Twisted/Bent
2
2
No Flow
2
2
Break
2
2
Fluid/Blood Leak
1
1
Gel Leak
1
1
No Device Output
1
1
Use of Device Problem
1
1
Material Split, Cut or Torn
1
1
Misassembled
1
1
Short Fill
1
1
Device Damaged Prior to Use
1
1
Contamination /Decontamination Problem
1
1
Device Markings/Labelling Problem
1
1
Moisture or Humidity Problem
1
1
Component Misassembled
1
1
Material Fragmentation
1
1
Unsealed Device Packaging
1
1
Patient-Device Incompatibility
1
1
Device Operates Differently Than Expected
1
1
Tear, Rip or Hole in Device Packaging
1
1
Device Contamination with Chemical or Other Material
1
1
Material Deformation
1
1
Physical Resistance/Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
14
14
No Clinical Signs, Symptoms or Conditions
6
6
No Consequences Or Impact To Patient
5
5
No Patient Involvement
5
5
Urinary Tract Infection
3
3
Patient Problem/Medical Problem
3
3
Pulmonary Infarction
1
1
Foreign Body In Patient
1
1
Unspecified Infection
1
1
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