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	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