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	1833	1833
Fluid/Blood Leak	1511	1511
Decrease in Pressure	1252	1252
Difficult to Remove	999	999
Deflation Problem	916	916
Failure to Infuse	900	900
Burst Container or Vessel	734	734
Material Rupture	363	363
Material Split, Cut or Torn	354	354
Material Fragmentation	324	324
Inflation Problem	239	239
Inaccurate Flow Rate	212	212
Short Fill	150	150
Leak/Splash	148	148
Component Misassembled	141	141
Material Twisted/Bent	141	141
Disconnection	126	126
Erratic or Intermittent Display	120	120
Fracture	118	118
Material Invagination	114	114
Partial Blockage	112	112
Device Contamination with Chemical or Other Material	103	103
Device Fell	102	102
Device Slipped	94	94
Component Missing	78	78
Material Protrusion/Extrusion	78	78
Break	77	77
Dent in Material	71	71
Gel Leak	64	64
Device Handling Problem	58	58
Tear, Rip or Hole in Device Packaging	46	46
Deformation Due to Compressive Stress	45	45
Physical Resistance/Sticking	43	43
Device Dislodged or Dislocated	39	39
Restricted Flow rate	39	39
Adverse Event Without Identified Device or Use Problem	32	32
Fitting Problem	29	29
Incorrect Measurement	26	26
No Display/Image	25	25
Material Discolored	25	25
No Flow	25	25
Nonstandard Device	24	24
Crack	21	21
Difficult to Insert	21	21
Use of Device Problem	18	18
Inadequate Instructions for Healthcare Professional	17	17
Illegible Information	16	16
Scratched Material	16	16
Biocompatibility	14	14
Complete Blockage	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7756	7756
No Consequences Or Impact To Patient	980	980
No Known Impact Or Consequence To Patient	858	858
No Patient Involvement	465	466
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	246	246
Foreign Body In Patient	84	84
Insufficient Information	81	81
Patient Problem/Medical Problem	59	59
Pain	51	51
No Code Available	45	45
Discomfort	38	38
Hematuria	31	31
Urinary Tract Infection	23	23
Tissue Breakdown	14	14
Urinary Retention	11	11
Unspecified Infection	10	10
Device Embedded In Tissue or Plaque	10	10
Hemorrhage/Bleeding	8	8
Abdominal Distention	6	6
Cancer	5	5
Sepsis	4	4
Fistula	3	3
Failure of Implant	3	3
No Information	3	3
Perforation	3	3
Hematoma	3	3
Unspecified Tissue Injury	3	3
Swelling/ Edema	3	3
Exposure to Body Fluids	3	3
Injury	3	3
Distress	2	2
Tissue Damage	2	2
Stenosis	2	2
Incontinence	2	2
Blood Loss	2	2
Skin Inflammation/ Irritation	2	2
Hypersensitivity/Allergic reaction	2	2
Death	2	2
Abdominal Pain	2	2
Chills	1	1
Irritation	1	1
Chest Pain	1	1
Burning Sensation	1	1
Rash	1	1
Hypothermia	1	1
Laceration(s)	1	1
Dyspnea	1	1
Bradycardia	1	1
Calcium Deposits/Calcification	1	1
Confusion/ Disorientation	1	1