TPLC - Total Product Life Cycle

show TPLC since

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	3303	3330
Fluid/Blood Leak	1528	1682
Deflation Problem	1139	1140
Decrease in Pressure	1001	1041
Difficult to Remove	958	961
Material Rupture	811	811
Failure to Infuse	792	855
Burst Container or Vessel	616	624
Material Split, Cut or Torn	425	427
Component Misassembled	392	392
Material Fragmentation	384	387
Inflation Problem	313	313
Inaccurate Flow Rate	294	295
Device Contamination with Chemical or Other Material	195	197
Disconnection	172	173
Material Twisted/Bent	165	167
Short Fill	146	147
Erratic or Intermittent Display	137	143
Partial Blockage	136	137
Fracture	132	134
Material Invagination	132	132
Component Missing	121	123
Complete Blockage	112	112
Material Protrusion/Extrusion	104	105
Device Dislodged or Dislocated	83	83
No Display/Image	71	73
Dent in Material	70	70
Gel Leak	64	64
Deformation Due to Compressive Stress	61	61
Device Handling Problem	54	57
Physical Resistance/Sticking	48	48
Tear, Rip or Hole in Device Packaging	42	44
Adverse Event Without Identified Device or Use Problem	31	32
Restricted Flow rate	31	31
Fitting Problem	29	31
Incorrect Measurement	29	30
Nonstandard Device	28	28
Wrong Label	22	22
Patient Device Interaction Problem	21	21
Difficult to Insert	20	20
Use of Device Problem	19	19
Scratched Material	19	19
Material Discolored	17	18
Illegible Information	16	16
Inability to Irrigate	11	11
Biocompatibility	10	10
Calcified	9	10
Sharp Edges	9	9
Unclear Information	7	7
Insufficient Device Problem Information	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11359	11565
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	307	311
No Consequences Or Impact To Patient	133	133
Foreign Body In Patient	102	102
Pain	67	67
Insufficient Information	54	68
Discomfort	52	52
No Patient Involvement	48	48
Hematuria	30	30
Urinary Tract Infection	21	21
No Code Available	16	16
Tissue Breakdown	14	14
Urinary Retention	14	14
Unspecified Infection	12	12
Urinary Incontinence	6	6
Abdominal Distention	6	6
Exposure to Body Fluids	5	5
Hemorrhage/Blood Loss/Bleeding	5	5
Cancer	5	6
Sepsis	4	4
Swelling/ Edema	4	4
Perforation	4	4
Abdominal Pain	3	3
Hematoma	3	3
Failure of Implant	3	3
Fistula	3	3
Bradycardia	3	3
Genital Bleeding	3	3
Unspecified Tissue Injury	3	3
Skin Inflammation/ Irritation	2	2
Incontinence	2	2
Fever	2	2
Stenosis	2	2
Hypersensitivity/Allergic reaction	2	2
Distress	2	2
Bacterial Infection	2	2
Micturition Urgency	2	2
Abrasion	1	1
High Blood Pressure/ Hypertension	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Irritation	1	1
Internal Organ Perforation	1	1
Chest Pain	1	1
Alteration in Body Temperature	1	1
Erosion	1	1
Chills	1	1
Hypothermia	1	1
Heart Failure/Congestive Heart Failure	1	1
Dyspnea	1	1
Irritability	1	1