TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	1	1
2016	7	7
2017	1	1
2018	3	3
2019	3	3
2020	6	6
2021	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Infusion or Flow Problem	10	10
Material Integrity Problem	7	7
Material Rupture	4	4
Suction Problem	4	4
No Device Output	3	3
No Display/Image	3	3
Display or Visual Feedback Problem	3	3
Fluid/Blood Leak	3	3
Decrease in Suction	2	2
Deflation Problem	2	2
Leak/Splash	2	2
Obstruction of Flow	2	2
Low Readings	1	1
Detachment of Device or Device Component	1	1
Improper Flow or Infusion	1	1
Compatibility Problem	1	1
Mechanical Problem	1	1
Unable to Obtain Readings	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Break	1	1
Complete Blockage	1	1
Crack	1	1
Inflation Problem	1	1
Material Protrusion/Extrusion	1	1
Output Problem	1	1
Insufficient Information	1	1
Device Fell	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Retention	5	5
No Consequences Or Impact To Patient	5	5
Unspecified Kidney or Urinary Problem	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Clinical Signs, Symptoms or Conditions	3	3
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