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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, irrigation, urological
Regulation Description Urological catheter and accessories.
Product CodeLJH
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
Free or Unrestricted Flow 7 7
Break 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
Mechanical Problem 1 1
Increase in Pressure 1 1
Reflux within 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
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
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Microbial Contamination of Device 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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