TPLC - Total Product Life Cycle

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Device	tray, catheterization, sterile urethral, with or without catheter (kit)
Regulation Description	Urological catheter and accessories.
Product Code	FCM
Regulation Number	876.5130
Device Class	2

Premarket Reviews
Manufacturer	Decision
COLOPLAST
	SUBSTANTIALLY EQUIVALENT	1
CONVATEC LIMITED
	SUBSTANTIALLY EQUIVALENT - KIT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Improper Chemical Reaction	45	45
Component Misassembled	34	35
Unintended Deflation	22	22
Component Missing	18	18
Fluid/Blood Leak	16	16
Material Twisted/Bent	16	16
Nonstandard Device	15	15
Adverse Event Without Identified Device or Use Problem	11	11
Gel Leak	10	10
Material Rupture	10	10
Material Fragmentation	10	11
Difficult to Insert	10	10
Biocompatibility	9	9
Deformation Due to Compressive Stress	7	7
Incorrect Measurement	7	7
Inaccurate Flow Rate	6	6
Disconnection	5	5
Partial Blockage	5	5
Obstruction of Flow	4	4
Material Split, Cut or Torn	3	5
No Flow	3	3
Premature Separation	3	3
Failure to Deflate	3	3
Deflation Problem	3	3
Product Quality Problem	3	3
Shipping Damage or Problem	3	3
Detachment of Device or Device Component	2	2
Sharp Edges	2	2
Infusion or Flow Problem	2	2
Contamination /Decontamination Problem	2	2
Difficult to Remove	2	2
Wrong Label	2	2
Inflation Problem	1	3
Delivered as Unsterile Product	1	1
Patient Device Interaction Problem	1	1
Material Deformation	1	1
Moisture Damage	1	1
Tear, Rip or Hole in Device Packaging	1	1
Unsealed Device Packaging	1	1
Material Protrusion/Extrusion	1	1
Illegible Information	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Unintended Movement	1	1
Complete Blockage	1	1
Suction Problem	1	1
Restricted Flow rate	1	1
Crack	1	1
Entrapment of Device	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	234	237
Urinary Tract Infection	25	25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Foreign Body In Patient	6	6
Insufficient Information	6	6
Unspecified Infection	3	3
No Code Available	3	3
Skin Inflammation/ Irritation	3	3
Discomfort	3	3
Pain	3	3
No Consequences Or Impact To Patient	3	3
Tissue Breakdown	2	2
Urinary Incontinence	1	1
Nausea	1	1
Failure of Implant	1	1
Hematuria	1	1
Abrasion	1	1
Burn(s)	1	1
Exposure to Body Fluids	1	1
Skin Tears	1	1
Pressure Sores	1	1
Hemorrhage/Bleeding	1	1
Irritability	1	1
Distress	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health	II	Dec-02-2022
2	Cardinal Health 200, LLC	I	Feb-16-2024
3	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
4	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
5	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022