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	382	386
Deformation Due to Compressive Stress	173	177
Fluid/Blood Leak	77	85
Component Misassembled	67	70
Component Missing	50	50
Material Twisted/Bent	46	46
Obstruction of Flow	33	33
Partial Blockage	28	29
Physical Resistance/Sticking	27	28
Disconnection	24	26
Adverse Event Without Identified Device or Use Problem	23	23
Deflation Problem	19	19
Material Fragmentation	19	24
No Flow	18	18
Biocompatibility	17	17
Device Contamination with Chemical or Other Material	16	16
Leak/Splash	15	15
Detachment of Device or Device Component	15	15
Inaccurate Flow Rate	13	17
Difficult to Open or Close	13	13
Material Split, Cut or Torn	12	12
Material Deformation	12	12
Nonstandard Device	11	12
Fracture	8	10
Improper Flow or Infusion	8	8
Incorrect Measurement	7	8
Device Handling Problem	7	7
Infusion or Flow Problem	7	7
Use of Device Problem	7	7
Unintended Deflation	6	6
Patient Device Interaction Problem	6	6
Material Too Soft/Flexible	6	6
Appropriate Term/Code Not Available	5	5
Break	5	5
Therapeutic or Diagnostic Output Failure	5	5
Material Puncture/Hole	5	6
Difficult to Remove	4	4
Difficult to Open or Remove Packaging Material	4	4
Defective Device	4	4
Illegible Information	4	4
Fungus in Device Environment	4	4
Material Rupture	4	4
Failure to Deflate	3	3
Inadequate Instructions for Healthcare Professional	3	3
Material Too Rigid or Stiff	3	3
Expiration Date Error	3	3
Defective Component	3	3
Inadequacy of Device Shape and/or Size	3	3
Short Fill	3	3
Activation Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	801	832
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	21	21
Urinary Retention	18	18
Unspecified Infection	17	17
Discomfort	16	16
Insufficient Information	13	13
Exposure to Body Fluids	8	8
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
Pressure Sores	3	3
Abdominal Distention	3	3
Foreign Body In Patient	3	3
Hemorrhage/Bleeding	3	3
Abdominal Pain	2	2
Sepsis	2	2
Distress	2	2
Abrasion	2	2
Itching Sensation	2	2
Purulent Discharge	2	2
Fever	2	2
Rash	2	2
Muscle Spasm(s)	2	2
Kidney Infection	1	1
Internal Organ Perforation	1	1
Thrombus	1	1
Therapeutic Effects, Unexpected	1	1
Bacterial Infection	1	1
Anxiety	1	1
Tachycardia	1	1
Fall	1	1
Scar Tissue	1	1
Swelling	1	1
Thrombosis/Thrombus	1	1
Burning Sensation	1	1
Chills	1	1
Injury	1	1
Irritation	1	1
Shock, Surgical	1	1
Skin Discoloration	1	1
Head Injury	1	1
Perforation	1	1

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