TPLC - Total Product Life Cycle

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Device	catheter, urological (antimicrobial) and accessories
Regulation Description	Urological catheter and accessories.
Product Code	MJC
Regulation Number	876.5130
Device Class	2

Premarket Reviews
Manufacturer	Decision
WELL LEAD MEDICAL (HAINAN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	2997	3024
Fluid/Blood Leak	1509	1663
Deflation Problem	1129	1130
Decrease in Pressure	997	1037
Difficult to Remove	920	923
Failure to Infuse	792	855
Material Rupture	706	706
Burst Container or Vessel	622	630
Material Split, Cut or Torn	406	408
Material Fragmentation	370	373
Component Misassembled	341	341
Inflation Problem	300	300
Inaccurate Flow Rate	287	288
Device Contamination with Chemical or Other Material	194	196
Disconnection	165	166
Material Twisted/Bent	160	162
Short Fill	146	147
Erratic or Intermittent Display	135	141
Partial Blockage	134	135
Material Invagination	130	130
Fracture	126	128
Component Missing	126	128
Complete Blockage	104	104
Material Protrusion/Extrusion	96	97
Device Dislodged or Dislocated	84	84
Dent in Material	70	70
Gel Leak	64	64
No Display/Image	60	62
Device Handling Problem	54	57
Deformation Due to Compressive Stress	54	54
Physical Resistance/Sticking	50	50
Tear, Rip or Hole in Device Packaging	43	45
Adverse Event Without Identified Device or Use Problem	31	32
Restricted Flow rate	29	29
Incorrect Measurement	29	30
Nonstandard Device	28	28
Fitting Problem	28	30
Material Discolored	26	35
Wrong Label	21	21
Difficult to Insert	19	19
Scratched Material	19	19
Use of Device Problem	18	18
Patient Device Interaction Problem	18	18
Illegible Information	16	16
Biocompatibility	11	11
Inability to Irrigate	10	10
Sharp Edges	9	9
Calcified	9	10
Defective Device	8	8
Insufficient Information	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10850	11056
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	287	291
No Consequences Or Impact To Patient	133	133
Foreign Body In Patient	93	93
Pain	59	59
Insufficient Information	53	67
No Patient Involvement	48	48
Discomfort	45	45
Hematuria	29	29
Urinary Tract Infection	21	21
No Code Available	16	16
Tissue Breakdown	14	14
Urinary Retention	13	13
Unspecified Infection	12	12
Abdominal Distention	6	6
Cancer	5	6
Urinary Incontinence	5	5
Exposure to Body Fluids	5	5
Hemorrhage/Bleeding	5	5
Sepsis	4	4
Hematoma	3	3
Failure of Implant	3	3
Fistula	3	3
Bradycardia	3	3
Swelling/ Edema	3	3
Unspecified Tissue Injury	3	3
Genital Bleeding	2	2
Skin Inflammation/ Irritation	2	2
Abdominal Pain	2	2
Micturition Urgency	2	2
Bacterial Infection	2	2
Fever	2	2
Hypersensitivity/Allergic reaction	2	2
Incontinence	2	2
Perforation	2	2
Distress	2	2
Stenosis	2	2
Pressure Sores	1	1
Chills	1	1
Irritation	1	1
Laceration(s)	1	1
Internal Organ Perforation	1	1
High Blood Pressure/ Hypertension	1	1
Hypothermia	1	1
Abrasion	1	1
Erosion	1	1
Calcium Deposits/Calcification	1	1
Chest Pain	1	1
Dyspnea	1	1
Cramp(s) /Muscle Spasm(s)	1	1