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	2709	2737
Fluid/Blood Leak	1718	1872
Deflation Problem	1541	1542
Decrease in Pressure	1252	1292
Difficult to Remove	1117	1120
Failure to Infuse	904	967
Burst Container or Vessel	735	743
Material Rupture	652	652
Material Split, Cut or Torn	452	454
Inflation Problem	390	390
Material Fragmentation	382	385
Inaccurate Flow Rate	302	303
Material Twisted/Bent	174	176
Device Contamination with Chemical or Other Material	169	171
Component Misassembled	168	168
Disconnection	165	166
Short Fill	159	160
Leak/Splash	150	150
Component Missing	144	146
Fracture	143	145
Partial Blockage	137	138
Material Invagination	136	136
Erratic or Intermittent Display	134	140
Device Dislodged or Dislocated	103	103
Device Fell	102	102
Complete Blockage	101	101
Material Protrusion/Extrusion	98	99
Device Slipped	94	94
Dent in Material	79	79
Break	77	80
Gel Leak	75	75
Device Handling Problem	58	61
Deformation Due to Compressive Stress	57	57
Physical Resistance/Sticking	54	54
No Display/Image	53	55
Tear, Rip or Hole in Device Packaging	49	51
Restricted Flow rate	40	40
Adverse Event Without Identified Device or Use Problem	33	34
Incorrect Measurement	32	33
Fitting Problem	31	33
Nonstandard Device	27	27
Material Discolored	27	36
No Flow	25	26
Use of Device Problem	24	24
Crack	22	22
Difficult to Insert	21	21
Wrong Label	20	20
Scratched Material	20	20
Illegible Information	17	17
Inadequate Instructions for Healthcare Professional	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10528	10734
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	291	295
Foreign Body In Patient	106	106
Insufficient Information	85	100
Pain	64	64
Patient Problem/Medical Problem	59	59
Discomfort	47	47
No Code Available	45	45
Hematuria	34	34
Urinary Tract Infection	24	24
Tissue Breakdown	14	14
Urinary Retention	13	13
Unspecified Infection	12	12
Device Embedded In Tissue or Plaque	10	10
Hemorrhage/Bleeding	8	8
Abdominal Distention	6	6
Cancer	5	6
Exposure to Body Fluids	5	5
Sepsis	4	4
Urinary Incontinence	4	4
Abdominal Pain	3	3
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
Injury	3	3
Distress	2	2
Bacterial Infection	2	2
Tissue Damage	2	2
Stenosis	2	2
Micturition Urgency	2	2
Incontinence	2	2
Blood Loss	2	2
Skin Inflammation/ Irritation	2	2
Hypersensitivity/Allergic reaction	2	2
Death	2	2
Chest Pain	1	1
Chills	1	1
Irritation	1	1
Hypothermia	1	1
Laceration(s)	1	1
Dyspnea	1	1
Bradycardia	1	1
Calcium Deposits/Calcification	1	1