TPLC - Total Product Life Cycle

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Device	system, irrigation, urological
Regulation Description	Urological catheter and accessories.
Product Code	LJH
Regulation Number	876.5130
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	44	44
Device Contamination with Chemical or Other Material	19	19
Detachment of Device or Device Component	8	8
Break	6	6
Disconnection	4	4
Incomplete or Inadequate Connection	4	4
Unsealed Device Packaging	4	4
Backflow	4	4
Leak/Splash	3	3
Filling Problem	3	3
Material Puncture/Hole	3	3
Defective Component	3	3
No Flow	3	3
Material Split, Cut or Torn	2	2
Tear, Rip or Hole in Device Packaging	2	2
Free or Unrestricted Flow	2	2
Fitting Problem	1	1
Mechanical Problem	1	1
Device Damaged Prior to Use	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Microbial Contamination of Device	1	1
Material Discolored	1	1
Material Twisted/Bent	1	1
Infusion or Flow Problem	1	1
Delivered as Unsterile Product	1	1
Material Deformation	1	1
Component Misassembled	1	1
Missing Information	1	1
Increase in Pressure	1	1
Device Dislodged or Dislocated	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	104	104
Insufficient Information	3	3
No Consequences Or Impact To Patient	2	2
Laceration(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Canadian Hospital Specialties	III	Nov-11-2022