TPLC - Total Product Life Cycle

show TPLC since

Device	collector, urine, (and accessories) for indwelling catheter
Product Code	KNX
Regulation Number	876.5250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Restricted Flow rate	413	413
Deformation Due to Compressive Stress	135	135
Component Missing	69	69
Component Misassembled	57	57
Material Twisted/Bent	56	56
Fluid/Blood Leak	49	49
Obstruction of Flow	49	49
No Flow	47	47
Partial Blockage	27	27
Adverse Event Without Identified Device or Use Problem	27	27
Physical Resistance/Sticking	27	27
Device Contamination with Chemical or Other Material	26	26
Deflation Problem	25	25
Leak/Splash	23	23
Disconnection	21	21
Material Deformation	20	20
Detachment of Device or Device Component	18	18
Biocompatibility	17	17
Infusion or Flow Problem	16	16
Inaccurate Flow Rate	15	15
Improper Flow or Infusion	14	14
Material Fragmentation	14	14
Backflow	12	12
Difficult to Open or Close	11	11
Nonstandard Device	11	11
Use of Device Problem	9	9
Expiration Date Error	9	9
Complete Blockage	8	8
Therapeutic or Diagnostic Output Failure	8	8
Device Markings/Labelling Problem	7	7
Difficult to Remove	7	7
Device Handling Problem	7	7
Break	7	7
Incorrect Measurement	6	6
Misassembled	6	6
Inadequate Instructions for Healthcare Professional	6	6
Patient Device Interaction Problem	6	6
Unintended Deflation	6	6
Suction Problem	6	6
Patient-Device Incompatibility	6	6
Material Split, Cut or Torn	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Defective Device	5	5
Appropriate Term/Code Not Available	5	5
Short Fill	5	5
Difficult to Open or Remove Packaging Material	4	4
Material Too Rigid or Stiff	4	4
Illegible Information	4	4
Material Puncture/Hole	4	4
Activation Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	588	588
No Consequences Or Impact To Patient	312	312
No Known Impact Or Consequence To Patient	233	233
No Patient Involvement	73	73
Urinary Tract Infection	54	54
Pain	28	28
Unspecified Infection	22	22
Urinary Retention	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Discomfort	16	16
Insufficient Information	12	12
Patient Problem/Medical Problem	6	6
No Code Available	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Foreign Body In Patient	4	4
Skin Inflammation/ Irritation	4	4
Hematuria	4	4
No Information	4	4
Abdominal Distention	3	3
Fever	3	3
Hemorrhage/Bleeding	3	3
Abdominal Pain	3	3
Abrasion	2	2
Itching Sensation	2	2
Skin Discoloration	2	2
Pressure Sores	2	2
Burning Sensation	2	2
Rash	2	2
Sepsis	2	2
Muscle Spasm(s)	2	2
Exposure to Body Fluids	2	2
Tissue Breakdown	1	1
Thrombus	1	1
Therapeutic Effects, Unexpected	1	1
Bacterial Infection	1	1
Internal Organ Perforation	1	1
Ulcer	1	1
Anxiety	1	1
Distress	1	1
Tachycardia	1	1
Ulceration	1	1
Fall	1	1
Scar Tissue	1	1
Micturition Urgency	1	1
Swelling	1	1
Erythema	1	1
Chills	1	1
Injury	1	1
Irritation	1	1
Shock, Surgical	1	1