TPLC - Total Product Life Cycle

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Device	catheter, retention type, balloon
Regulation Description	Urological catheter and accessories.
Product Code	EZL
Regulation Number	876.5130
Device Class	2

Premarket Reviews
Manufacturer	Decision
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT	1
FLUME CATHETER COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG ECAN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOCARE UROLOGICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
POTRERO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
SENTINEL MEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SILQ TECHNOLOGIES CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SILQ TECHNOLOGIES, CORP.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEXMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
THE FLUME CATHETER COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	710	730
Burst Container or Vessel	543	547
Material Rupture	451	457
Fluid/Blood Leak	377	386
Difficult to Remove	302	306
Material Split, Cut or Torn	194	196
Decrease in Pressure	188	194
Deflation Problem	187	187
Inflation Problem	179	179
Material Invagination	178	190
Material Fragmentation	157	159
Adverse Event Without Identified Device or Use Problem	125	126
Failure to Deflate	114	114
Partial Blockage	109	109
Inaccurate Flow Rate	103	106
Unintended Deflation	96	96
Erratic or Intermittent Display	95	95
Break	87	88
Device Contamination with Chemical or Other Material	85	87
Component Missing	73	73
Component Misassembled	67	68
Leak/Splash	63	64
Failure to Infuse	58	63
Fracture	57	57
Wrong Label	51	51
Patient Device Interaction Problem	49	49
Device Dislodged or Dislocated	49	50
Device Contaminated During Manufacture or Shipping	48	48
Obstruction of Flow	42	48
Material Integrity Problem	39	39
Insufficient Information	35	35
Material Protrusion/Extrusion	34	37
Complete Blockage	32	32
Detachment of Device or Device Component	31	31
Tear, Rip or Hole in Device Packaging	31	31
Incorrect Measurement	31	33
Disconnection	30	30
Appropriate Term/Code Not Available	29	29
Nonstandard Device	29	30
Material Twisted/Bent	29	32
Improper or Incorrect Procedure or Method	26	26
Dent in Material	26	28
Calcified	25	25
Deformation Due to Compressive Stress	25	26
Difficult to Insert	22	22
Short Fill	21	21
Material Separation	20	20
Defective Device	20	20
No Display/Image	20	20
No Flow	20	20

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3998	4056
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	332	343
Insufficient Information	284	292
Pain	270	282
Discomfort	135	138
Urinary Tract Infection	130	131
Foreign Body In Patient	75	75
Hematuria	74	74
Urinary Retention	67	67
Hemorrhage/Bleeding	43	49
No Consequences Or Impact To Patient	30	30
Skin Inflammation/ Irritation	21	22
Exposure to Body Fluids	17	17
Genital Bleeding	16	16
Unspecified Infection	15	15
No Known Impact Or Consequence To Patient	11	11
Dysuria	10	10
Sepsis	9	9
Burning Sensation	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Unspecified Tissue Injury	8	8
Swelling/ Edema	8	8
Inflammation	8	8
Tissue Breakdown	7	7
Urinary Incontinence	6	6
Skin Tears	6	6
Perforation	6	6
Incontinence	6	6
No Patient Involvement	6	6
Pressure Sores	5	5
Unspecified Kidney or Urinary Problem	5	5
Rash	5	5
Fistula	5	5
Fungal Infection	4	4
Abrasion	4	5
Anemia	4	4
Cancer	4	4
Internal Organ Perforation	4	4
Fever	4	4
Septic Shock	4	4
Erosion	3	3
Necrosis	3	3
Dizziness	3	3
No Code Available	3	3
Ulcer	3	3
Anxiety	3	3
Chemical Exposure	3	3
Fluid Discharge	3	3
Cellulitis	3	3
Skin Discoloration	3	5

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	May-21-2026
2	C.R. Bard Inc	II	Aug-28-2025
3	C.R. Bard Inc	II	Sep-23-2021
4	Cardinal Health 200, LLC	I	Feb-16-2024
5	Coloplast Manufacturing US, LLC	II	Jan-10-2025
6	Nurse Assist, LLC	I	Dec-20-2023