TPLC - Total Product Life Cycle

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Device	catheter, urological
Regulation Description	Urological catheter and accessories.
Product Code	KOD
Regulation Number	876.5130
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	857	857
Improper Chemical Reaction	445	445
Adverse Event Without Identified Device or Use Problem	433	433
Difficult to Remove	429	429
Material Twisted/Bent	317	317
Component Misassembled	314	314
Material Rupture	292	292
Decrease in Pressure	255	255
Deflation Problem	249	249
Material Puncture/Hole	247	247
Sharp Edges	222	222
Fluid/Blood Leak	191	191
Incorrect Measurement	191	191
Difficult to Insert	187	187
Partial Blockage	153	153
Short Fill	153	153
Device Misassembled During Manufacturing /Shipping	143	143
Tear, Rip or Hole in Device Packaging	136	136
Nonstandard Device	136	136
Component Missing	126	126
Biocompatibility	121	121
Contamination /Decontamination Problem	110	110
Material Fragmentation	101	101
Inaccurate Flow Rate	101	101
Failure to Infuse	95	95
Material Split, Cut or Torn	90	90
Leak/Splash	75	75
Patient Device Interaction Problem	70	70
Unsealed Device Packaging	67	67
Material Too Rigid or Stiff	67	67
Device Handling Problem	65	65
Product Quality Problem	60	60
Break	59	59
Material Protrusion/Extrusion	52	52
Difficult to Open or Remove Packaging Material	52	52
Device Contamination with Chemical or Other Material	45	45
Unintended Deflation	42	42
Inflation Problem	42	42
Device Slipped	42	42
Inability to Irrigate	40	40
Inadequacy of Device Shape and/or Size	38	38
Defective Device	35	35
Device Fell	34	34
Deformation Due to Compressive Stress	33	33
Material Separation	32	32
Device Contaminated During Manufacture or Shipping	31	31
Failure to Deflate	31	31
Naturally Worn	29	29
Obstruction of Flow	26	26
Material Deformation	26	26

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4118	4118
No Consequences Or Impact To Patient	807	807
No Known Impact Or Consequence To Patient	469	469
Pain	453	453
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	440	440
Urinary Tract Infection	436	436
No Patient Involvement	181	181
Discomfort	177	177
Hemorrhage/Bleeding	99	99
Patient Problem/Medical Problem	93	93
Hematuria	83	83
Insufficient Information	66	66
Foreign Body In Patient	65	65
Blood Loss	63	63
Unspecified Tissue Injury	60	60
Unspecified Infection	52	52
Bacterial Infection	52	52
No Code Available	49	49
Urinary Retention	35	35
Sepsis	26	26
Abdominal Distention	26	26
Skin Inflammation/ Irritation	25	25
Tissue Breakdown	25	25
Abdominal Pain	15	15
Perforation	15	15
Abrasion	15	15
Swelling/ Edema	14	14
Bruise/Contusion	13	13
Irritability	12	12
Exposure to Body Fluids	11	11
Irritation	11	11
Fistula	11	11
Incontinence	11	11
Laceration(s)	10	10
Fever	10	10
Obstruction/Occlusion	9	9
Skin Discoloration	8	8
Injury	8	8
Genital Bleeding	8	8
Cramp(s) /Muscle Spasm(s)	7	7
Inflammation	7	7
Hematoma	7	7
Cancer	7	7
Septic Shock	7	7
Urinary Incontinence	7	7
Anemia	6	6
Abscess	6	6
Low Blood Pressure/ Hypotension	6	6
Dysuria	6	6
Burning Sensation	6	6