TPLC - Total Product Life Cycle

• Device: tray, catheterization, sterile urethral, with or without catheter (kit)
• Product Code: FCM
• Regulation Number: 876.5130
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
COLOPLAST
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	79	79
2020	86	86
2021	85	85
2022	59	59
2023	48	48
2024	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Component Missing	45	45
Improper Chemical Reaction	40	40
Component Misassembled	30	30
Difficult to Insert	30	30
Product Quality Problem	23	23
Material Twisted/Bent	20	20
Fluid/Blood Leak	19	19
Adverse Event Without Identified Device or Use Problem	18	18
Biocompatibility	18	18
Nonstandard Device	16	16
Inaccurate Flow Rate	13	13
Unintended Deflation	13	13
Incorrect Measurement	12	12
Patient-Device Incompatibility	11	11
Defective Device	9	9
Misassembled	9	9
Deflation Problem	8	8
Material Integrity Problem	8	8
Deformation Due to Compressive Stress	7	7
Material Fragmentation	7	7
Gel Leak	7	7
Leak/Splash	6	6
Detachment of Device or Device Component	6	6
Material Deformation	6	6
Sharp Edges	6	6
No Flow	5	5
Partial Blockage	5	5
Material Rupture	5	5
Inadequacy of Device Shape and/or Size	4	4
Break	4	4
Contamination /Decontamination Problem	4	4
Structural Problem	4	4
Tear, Rip or Hole in Device Packaging	3	3
Therapeutic or Diagnostic Output Failure	3	3
Insufficient Information	3	3
Burst Container or Vessel	3	3
Disconnection	3	3
Shipping Damage or Problem	3	3
Premature Separation	3	3
Material Split, Cut or Torn	3	3
Inadequate Lubrication	3	3
Failure to Deflate	3	3
Improper or Incorrect Procedure or Method	2	2
Difficult to Remove	2	2
Unsealed Device Packaging	2	2
Material Protrusion/Extrusion	2	2
Packaging Problem	2	2
Obstruction of Flow	2	2
Defective Component	2	2
Device Dislodged or Dislocated	2	2
Infusion or Flow Problem	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Device Ingredient or Reagent Problem	1	1
Device Markings/Labelling Problem	1	1
Incomplete or Missing Packaging	1	1
Fungus in Device Environment	1	1
Positioning Problem	1	1
Scratched Material	1	1
Moisture or Humidity Problem	1	1
Device Handling Problem	1	1
Patient Device Interaction Problem	1	1
Material Too Soft/Flexible	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Material Puncture/Hole	1	1
Moisture Damage	1	1
Delivered as Unsterile Product	1	1
Suction Problem	1	1
Use of Device Problem	1	1
Short Fill	1	1
Material Separation	1	1
Restricted Flow rate	1	1
Material Discolored	1	1
Complete Blockage	1	1
Loose or Intermittent Connection	1	1
Labelling, Instructions for Use or Training Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Inflation Problem	1	1
Fracture	1	1
Physical Resistance/Sticking	1	1
Illegible Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	189	189
No Consequences Or Impact To Patient	84	84
No Known Impact Or Consequence To Patient	81	81
Urinary Tract Infection	38	38
No Patient Involvement	30	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Pain	10	10
Hemorrhage/Bleeding	8	8
Patient Problem/Medical Problem	8	8
Insufficient Information	7	7
Discomfort	6	6
Blood Loss	5	5
Foreign Body In Patient	5	5
No Code Available	5	5
Unspecified Infection	3	3
Abrasion	2	2
Sepsis	2	2
Tissue Damage	2	2
Tissue Breakdown	2	2
Hematuria	2	2
Skin Inflammation/ Irritation	1	1
Urinary Incontinence	1	1
Urinary Retention	1	1
Pressure Sores	1	1
Distress	1	1
Injury	1	1
Irritability	1	1
Skin Tears	1	1
Exposure to Body Fluids	1	1
Burn(s)	1	1
Failure of Implant	1	1
Nausea	1	1
Staphylococcus Aureus	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	Aug-03-2023
4	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022