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TPLC
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Device
system, irrigation, urological
Regulation Description
Urological catheter and accessories.
Product Code
LJH
Regulation Number
876.5130
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
23
23
2021
15
15
2022
21
21
2023
34
34
2024
13
13
2025
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
41
41
Device Contamination with Chemical or Other Material
25
25
Detachment of Device or Device Component
11
11
Break
7
7
Free or Unrestricted Flow
7
7
Backflow
4
4
No Flow
4
4
Incomplete or Inadequate Connection
4
4
Disconnection
3
3
Filling Problem
3
3
Defective Component
3
3
Tear, Rip or Hole in Device Packaging
3
3
Unsealed Device Packaging
2
2
Material Puncture/Hole
2
2
Defective Device
2
2
Improper Flow or Infusion
2
2
Material Discolored
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Protective Measures Problem
1
1
Component Misassembled
1
1
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Mechanical Problem
1
1
Increase in Pressure
1
1
Reflux within Device
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Microbial Contamination of Device
1
1
Contamination /Decontamination Problem
1
1
Difficult to Open or Close
1
1
Device Dislodged or Dislocated
1
1
Infusion or Flow Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
89
89
No Patient Involvement
10
10
No Consequences Or Impact To Patient
8
8
No Known Impact Or Consequence To Patient
5
5
Insufficient Information
4
4
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Canadian Hospital Specialties
III
Nov-11-2022
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