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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
2015
5
5
2017
8
8
2018
14
14
2019
4
4
2020
2
2
2021
1
1
2022
5
5
2023
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Component Missing
6
6
No Flow
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Disconnection
4
4
Inaccurate Flow Rate
4
4
Material Fragmentation
3
3
Hole In Material
3
3
Leak/Splash
3
3
Difficult to Remove
3
3
Fitting Problem
3
3
Break
2
2
Component Misassembled
2
2
Material Twisted/Bent
2
2
Improper or Incorrect Procedure or Method
2
2
Moisture or Humidity Problem
1
1
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Tear, Rip or Hole in Device Packaging
1
1
Defective Device
1
1
Patient-Device Incompatibility
1
1
Contamination /Decontamination Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Markings/Labelling Problem
1
1
Device Operates Differently Than Expected
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Contamination with Chemical or Other Material
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Bent
1
1
Fluid/Blood Leak
1
1
Kinked
1
1
Gel Leak
1
1
Device Damaged Prior to Use
1
1
Short Fill
1
1
Use of Device Problem
1
1
Loose or Intermittent Connection
1
1
Misassembled
1
1
No Device Output
1
1
Unsealed Device Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
19
19
No Clinical Signs, Symptoms or Conditions
15
15
No Consequences Or Impact To Patient
6
6
No Patient Involvement
5
5
Unspecified Infection
5
5
Urinary Tract Infection
3
3
Patient Problem/Medical Problem
3
3
Foreign Body In Patient
2
2
No Information
2
2
Insufficient Information
2
2
Bacterial Infection
1
1
Pulmonary Infarction
1
1
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