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	3294	3322
Fluid/Blood Leak	1771	1925
Deflation Problem	1569	1570
Decrease in Pressure	1262	1302
Difficult to Remove	1187	1190
Failure to Infuse	909	972
Material Rupture	807	807
Burst Container or Vessel	737	745
Material Split, Cut or Torn	496	498
Inflation Problem	423	423
Material Fragmentation	401	404
Component Misassembled	393	393
Inaccurate Flow Rate	321	322
Device Contamination with Chemical or Other Material	212	214
Material Twisted/Bent	190	192
Disconnection	177	178
Short Fill	159	160
Leak/Splash	150	150
Fracture	148	150
Component Missing	146	148
Erratic or Intermittent Display	141	147
Partial Blockage	140	141
Material Invagination	138	138
Device Dislodged or Dislocated	117	117
Complete Blockage	111	111
Material Protrusion/Extrusion	110	111
Device Fell	102	102
Device Slipped	94	94
Dent in Material	80	80
Break	77	80
Gel Leak	77	77
No Display/Image	64	66
Deformation Due to Compressive Stress	62	62
Device Handling Problem	58	61
Physical Resistance/Sticking	57	57
Tear, Rip or Hole in Device Packaging	52	54
Restricted Flow rate	42	42
Incorrect Measurement	34	35
Adverse Event Without Identified Device or Use Problem	34	35
Fitting Problem	32	34
Nonstandard Device	29	29
Material Discolored	27	36
Use of Device Problem	26	26
No Flow	25	26
Wrong Label	22	22
Difficult to Insert	22	22
Crack	22	22
Patient Device Interaction Problem	21	21
Scratched Material	20	20
Illegible Information	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11412	11618
No Consequences Or Impact To Patient	980	980
No Known Impact Or Consequence To Patient	858	859
No Patient Involvement	465	466
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	318	322
Foreign Body In Patient	117	117
Insufficient Information	85	100
Pain	65	65
Patient Problem/Medical Problem	59	59
Discomfort	50	50
No Code Available	45	45
Hematuria	36	36
Urinary Tract Infection	25	25
Urinary Retention	17	17
Tissue Breakdown	14	14
Unspecified Infection	12	12
Device Embedded In Tissue or Plaque	10	10
Hemorrhage/Bleeding	8	8
Urinary Incontinence	6	6
Abdominal Distention	6	6
Cancer	5	6
Perforation	5	5
Exposure to Body Fluids	5	5
Abdominal Pain	4	4
Sepsis	4	4
Injury	3	3
Fistula	3	3
Hematoma	3	3
No Information	3	3
Genital Bleeding	3	3
Failure of Implant	3	3
Bradycardia	3	3
Unspecified Tissue Injury	3	3
Swelling/ Edema	3	3
Incontinence	2	2
Distress	2	2
Fever	2	2
Blood Loss	2	2
Death	2	2
Micturition Urgency	2	2
Skin Inflammation/ Irritation	2	2
Hypersensitivity/Allergic reaction	2	2
Bacterial Infection	2	2
Stenosis	2	2
Tissue Damage	2	2
Bruise/Contusion	1	1
High Blood Pressure/ Hypertension	1	1
Internal Organ Perforation	1	1
Irritability	1	1
Pressure Sores	1	1