TPLC - Total Product Life Cycle

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Device	catheter, upper urinary tract
Regulation Description	Urological catheter and accessories.
Product Code	EYC
Regulation Number	876.5130
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	14	14
Fluid/Blood Leak	12	12
Complete Blockage	10	10
Expulsion	10	10
Obstruction of Flow	9	9
Burst Container or Vessel	8	8
Failure to Sense	5	5
Material Integrity Problem	5	5
Suction Problem	4	4
Infusion or Flow Problem	4	4
Material Rupture	4	4
Blocked Connection	4	4
Unable to Obtain Readings	2	2
Material Separation	2	2
Decrease in Suction	2	2
Display or Visual Feedback Problem	2	2
Leak/Splash	2	2
Unintended Deflation	2	2
Therapeutic or Diagnostic Output Failure	1	1
Insufficient Information	1	1
Device Fell	1	1
Gas/Air Leak	1	1
Compatibility Problem	1	1
Mechanical Problem	1	1
Peeled/Delaminated	1	1
Failure to Power Up	1	1
Material Puncture/Hole	1	1
Break	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Decreased Sensitivity	1	1
Patient-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	24
Urinary Retention	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Unspecified Kidney or Urinary Problem	4	4
Urinary Incontinence	2	2
No Known Impact Or Consequence To Patient	2	2
Abdominal Pain	1	1
Foreign Body In Patient	1	1
Insufficient Information	1	1
Partial thickness (Second Degree) Burn	1	1
Urinary Tract Infection	1	1