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	652	672
Burst Container or Vessel	515	519
Material Rupture	415	421
Fluid/Blood Leak	344	353
Difficult to Remove	284	288
Material Split, Cut or Torn	188	190
Decrease in Pressure	188	194
Deflation Problem	184	184
Material Invagination	174	186
Inflation Problem	165	165
Material Fragmentation	152	154
Adverse Event Without Identified Device or Use Problem	122	123
Partial Blockage	107	107
Failure to Deflate	101	101
Erratic or Intermittent Display	95	95
Inaccurate Flow Rate	92	95
Break	83	84
Device Contamination with Chemical or Other Material	79	81
Unintended Deflation	73	73
Component Missing	69	69
Leak/Splash	63	64
Component Misassembled	62	63
Failure to Infuse	56	61
Fracture	50	50
Patient Device Interaction Problem	48	48
Device Dislodged or Dislocated	48	49
Wrong Label	48	48
Device Contaminated During Manufacture or Shipping	43	43
Obstruction of Flow	37	43
Material Integrity Problem	36	36
Insufficient Information	34	34
Material Protrusion/Extrusion	32	35
Incorrect Measurement	31	33
Detachment of Device or Device Component	29	29
Tear, Rip or Hole in Device Packaging	29	29
Complete Blockage	28	28
Appropriate Term/Code Not Available	28	28
Nonstandard Device	27	28
Material Twisted/Bent	27	30
Dent in Material	26	28
Disconnection	25	25
Calcified	24	24
Deformation Due to Compressive Stress	24	25
Short Fill	21	21
Difficult to Insert	21	21
Material Separation	20	20
Defective Device	20	20
No Flow	20	20
Material Deformation	19	20
Gel Leak	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3778	3836
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	317	328
Insufficient Information	272	280
Pain	254	266
Urinary Tract Infection	128	129
Discomfort	113	116
Hematuria	74	74
Foreign Body In Patient	72	72
Urinary Retention	62	62
Hemorrhage/Bleeding	42	48
No Consequences Or Impact To Patient	30	30
Skin Inflammation/ Irritation	21	22
Genital Bleeding	16	16
Exposure to Body Fluids	16	16
Unspecified Infection	15	15
No Known Impact Or Consequence To Patient	11	11
Sepsis	9	9
Unspecified Tissue Injury	8	8
Burning Sensation	7	7
Skin Tears	6	6
No Patient Involvement	6	6
Tissue Breakdown	6	6
Perforation	6	6
Incontinence	6	6
Urinary Incontinence	6	6
Cramp(s) /Muscle Spasm(s)	6	6
Unspecified Kidney or Urinary Problem	5	5
Rash	5	5
Fistula	5	5
Pressure Sores	5	5
Cancer	4	4
Abrasion	4	5
Internal Organ Perforation	4	4
Septic Shock	4	4
Fever	4	4
Inflammation	4	4
Swelling/ Edema	4	4
Kidney Infection	3	3
Laceration(s)	3	3
Necrosis	3	3
Skin Discoloration	3	5
Anemia	3	3
Erosion	3	3
Cellulitis	3	3
Micturition Urgency	3	3
No Code Available	3	3
Device Embedded In Tissue or Plaque	3	3
Dysuria	3	3
Intraoperative Pain	3	3
Anxiety	3	3

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