TPLC - Total Product Life Cycle

show TPLC since

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	321	325
Deformation Due to Compressive Stress	155	159
Fluid/Blood Leak	74	82
Component Misassembled	70	73
Material Twisted/Bent	34	34
Component Missing	28	28
Disconnection	26	28
Physical Resistance/Sticking	25	26
Partial Blockage	21	22
Obstruction of Flow	21	21
Material Fragmentation	19	24
Device Contamination with Chemical or Other Material	17	17
Difficult to Open or Close	15	15
Adverse Event Without Identified Device or Use Problem	14	14
Inaccurate Flow Rate	12	16
Nonstandard Device	12	13
Leak/Splash	10	10
Fracture	10	12
Material Too Soft/Flexible	10	10
Material Split, Cut or Torn	9	9
Patient Device Interaction Problem	7	7
Deflation Problem	6	6
Unintended Deflation	6	6
Material Puncture/Hole	6	7
Fungus in Device Environment	5	5
Use of Device Problem	5	5
Improper Flow or Infusion	5	5
Device Handling Problem	5	5
Detachment of Device or Device Component	5	5
Incorrect Measurement	5	6
No Flow	4	4
Appropriate Term/Code Not Available	4	4
Illegible Information	4	4
Difficult to Open or Remove Packaging Material	4	4
Inadequate Instructions for Healthcare Professional	3	3
Defective Device	3	3
Expiration Date Error	3	3
Failure to Deflate	3	3
Activation Problem	3	3
Material Rupture	3	3
Biocompatibility	3	3
Fitting Problem	3	3
Inadequate or Insufficient Training	2	2
Inaccurate Information	2	2
Melted	2	2
Calcified	2	2
Missing Information	2	3
Tear, Rip or Hole in Device Packaging	2	2
Inadequacy of Device Shape and/or Size	2	2
Failure to Capture	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	834	865
Urinary Tract Infection	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	23
No Consequences Or Impact To Patient	23	23
Pain	23	23
Insufficient Information	17	17
Urinary Retention	17	17
Unspecified Infection	16	16
Discomfort	11	11
Exposure to Body Fluids	8	8
Cramp(s) /Muscle Spasm(s)	5	5
Skin Inflammation/ Irritation	4	4
Micturition Urgency	4	4
Pressure Sores	3	3
Hematuria	3	3
Abdominal Distention	3	3
Distress	2	2
No Patient Involvement	2	2
Rash	2	2
Fever	2	2
Itching Sensation	2	2
Purulent Discharge	2	2
Abrasion	2	2
Sepsis	2	2
Skin Discoloration	1	1
Burning Sensation	1	1
Chills	1	1
Foreign Body In Patient	1	1
Thrombosis/Thrombus	1	1
Perforation	1	1
Head Injury	1	1
No Code Available	1	1
Fungal Infection	1	1
Muscle Spasm(s)	1	1
Brain Injury	1	1
Fall	1	1
Scar Tissue	1	1
Tachycardia	1	1
Anxiety	1	1
Nausea	1	1
Hyperplasia	1	1
Hemorrhage/Bleeding	1	1
Internal Organ Perforation	1	1
Abdominal Pain	1	1
Kidney Infection	1	1

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