TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Restricted Flow rate	346	346
Deformation Due to Compressive Stress	141	141
Component Misassembled	63	63
Fluid/Blood Leak	54	54
Component Missing	48	48
Material Twisted/Bent	42	42
Obstruction of Flow	33	33
Partial Blockage	27	27
Physical Resistance/Sticking	25	25
Adverse Event Without Identified Device or Use Problem	22	22
No Flow	18	18
Deflation Problem	18	18
Disconnection	17	17
Biocompatibility	17	17
Leak/Splash	15	15
Detachment of Device or Device Component	15	15
Device Contamination with Chemical or Other Material	15	15
Material Fragmentation	14	14
Inaccurate Flow Rate	12	12
Material Deformation	12	12
Nonstandard Device	11	11
Difficult to Open or Close	11	11
Improper Flow or Infusion	8	8
Use of Device Problem	7	7
Infusion or Flow Problem	7	7
Material Split, Cut or Torn	7	7
Device Handling Problem	7	7
Material Too Soft/Flexible	6	6
Unintended Deflation	6	6
Patient Device Interaction Problem	6	6
Incorrect Measurement	6	6
Appropriate Term/Code Not Available	5	5
Fracture	5	5
Therapeutic or Diagnostic Output Failure	5	5
Break	5	5
Difficult to Remove	4	4
Illegible Information	4	4
Material Puncture/Hole	4	4
Difficult to Open or Remove Packaging Material	4	4
Material Rupture	4	4
Fungus in Device Environment	3	3
Expiration Date Error	3	3
Defective Device	3	3
Failure to Deflate	3	3
Inadequate Instructions for Healthcare Professional	3	3
Missing Information	3	3
Short Fill	3	3
Material Too Rigid or Stiff	3	3
Complete Blockage	3	3
Activation Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	679	679
No Consequences Or Impact To Patient	155	155
No Known Impact Or Consequence To Patient	93	93
Urinary Tract Infection	42	42
No Patient Involvement	36	36
Pain	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Unspecified Infection	17	17
Urinary Retention	17	17
Discomfort	16	16
Insufficient Information	12	12
Exposure to Body Fluids	7	7
Cramp(s) /Muscle Spasm(s)	5	5
Patient Problem/Medical Problem	4	4
No Code Available	4	4
Hematuria	4	4
Skin Inflammation/ Irritation	4	4
Micturition Urgency	4	4
Abdominal Distention	3	3
Foreign Body In Patient	3	3
Hemorrhage/Bleeding	3	3
Abdominal Pain	2	2
Sepsis	2	2
Abrasion	2	2
Purulent Discharge	2	2
Itching Sensation	2	2
Fever	2	2
Rash	2	2
Pressure Sores	2	2
Muscle Spasm(s)	2	2
Kidney Infection	1	1
Distress	1	1
Thrombus	1	1
Internal Organ Perforation	1	1
Therapeutic Effects, Unexpected	1	1
Bacterial Infection	1	1
Anxiety	1	1
Tachycardia	1	1
Scar Tissue	1	1
Fall	1	1
Swelling	1	1
Thrombosis/Thrombus	1	1
Injury	1	1
Shock, Surgical	1	1
Chills	1	1
Burning Sensation	1	1
Irritation	1	1
Skin Discoloration	1	1
Perforation	1	1
Head Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	I	Feb-16-2024