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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
Product CodeLJH
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2019 16 16
2020 23 23
2021 15 15
2022 21 21
2023 34 34
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 43 43
Device Contamination with Chemical or Other Material 23 23
Detachment of Device or Device Component 11 11
Break 8 8
Free or Unrestricted Flow 7 7
Disconnection 4 4
Incomplete or Inadequate Connection 4 4
Backflow 4 4
Improper Flow or Infusion 4 4
No Flow 4 4
Filling Problem 3 3
Defective Component 3 3
Tear, Rip or Hole in Device Packaging 3 3
Fitting Problem 2 2
Defective Device 2 2
Mechanical Problem 1 1
Reflux within Device 1 1
Physical Resistance/Sticking 1 1
Device Damaged Prior to Use 1 1
Material Puncture/Hole 1 1
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Microbial Contamination of Device 1 1
Contamination /Decontamination Problem 1 1
Material Discolored 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Infusion or Flow Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Partial Blockage 1 1
Failure to Prime 1 1
Increase in Pressure 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 77
No Patient Involvement 21 21
No Consequences Or Impact To Patient 11 11
No Known Impact Or Consequence To Patient 7 7
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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