TPLC - Total Product Life Cycle

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Device	bag, urine collection, leg, for external use, sterile
Regulation Description	Urine collector and accessories.
Product Code	FAQ
Regulation Number	876.5250
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Restricted Flow rate	105	117
Component Missing	26	27
Biocompatibility	15	15
Deformation Due to Compressive Stress	14	14
Material Twisted/Bent	8	8
Component Misassembled	6	6
Complete Blockage	5	5
Adverse Event Without Identified Device or Use Problem	5	6
Partial Blockage	4	4
Physical Resistance/Sticking	3	3
Material Rupture	3	3
Nonstandard Device	3	3
Insufficient Information	2	2
Obstruction of Flow	2	2
Incorrect Measurement	2	2
No Apparent Adverse Event	2	2
No Flow	2	2
Disconnection	1	2
Device Contaminated During Manufacture or Shipping	1	1
Collapse	1	1
Wrong Label	1	1
Defective Component	1	2
Inadequate Instructions for Healthcare Professional	1	1
Patient Device Interaction Problem	1	1
Material Fragmentation	1	1
Inaccurate Flow Rate	1	1
Infusion or Flow Problem	1	1
Device Handling Problem	1	1
Tear, Rip or Hole in Device Packaging	1	2
Device Contamination with Chemical or Other Material	1	1
Illegible Information	1	1
Inadequate or Insufficient Training	1	1
Fungus in Device Environment	1	1
Difficult to Open or Close	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	169	184
Urinary Tract Infection	23	24
Sepsis	7	7
Discomfort	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Urinary Retention	4	4
Insufficient Information	3	3
Unspecified Infection	2	2
Skin Inflammation/ Irritation	2	2
No Patient Involvement	1	1
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-30-2024