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	108	120
Component Missing	26	27
Deformation Due to Compressive Stress	15	15
Biocompatibility	15	15
Material Twisted/Bent	8	8
Complete Blockage	6	6
Component Misassembled	6	6
Adverse Event Without Identified Device or Use Problem	5	6
Physical Resistance/Sticking	4	4
Partial Blockage	4	4
Material Rupture	3	3
Nonstandard Device	3	3
Obstruction of Flow	2	2
Insufficient Device Problem Information	2	2
Inaccurate Flow Rate	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
Use of Device Problem	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	175	190
Urinary Tract Infection	23	24
Sepsis	7	7
Urinary Retention	5	5
Discomfort	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Insufficient Information	4	4
Unspecified Infection	2	2
Skin Inflammation/ Irritation	2	2
No Patient Involvement	1	1
Skin Tears	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