TPLC - Total Product Life Cycle

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Device	catheter, upper urinary tract
Product Code	EYC
Regulation Number	876.5130
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	13	13
Device Dislodged or Dislocated	12	12
Obstruction of Flow	11	11
Complete Blockage	11	11
Expulsion	10	10
Infusion or Flow Problem	10	10
Material Integrity Problem	7	7
Burst Container or Vessel	6	6
Material Rupture	4	4
Suction Problem	4	4
No Display/Image	3	3
No Device Output	3	3
Display or Visual Feedback Problem	3	3
Leak/Splash	2	2
Deflation Problem	2	2
Decrease in Suction	2	2
Improper Flow or Infusion	1	1
Gas/Air Leak	1	1
Compatibility Problem	1	1
Output Problem	1	1
Break	1	1
Mechanical Problem	1	1
Crack	1	1
Failure to Sense	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Protrusion/Extrusion	1	1
Decreased Sensitivity	1	1
Detachment of Device or Device Component	1	1
Low Readings	1	1
Device Fell	1	1
Insufficient Information	1	1
Material Puncture/Hole	1	1
Unable to Obtain Readings	1	1
Material Deformation	1	1
Inflation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Retention	24	24
No Clinical Signs, Symptoms or Conditions	10	10
No Consequences Or Impact To Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Unspecified Kidney or Urinary Problem	4	4
No Known Impact Or Consequence To Patient	3	3
Discomfort	3	3
Urinary Incontinence	2	2
Fever	2	2
Abdominal Pain	1	1
Blood Loss	1	1
No Patient Involvement	1	1