TPLC - Total Product Life Cycle

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Device	catheter, straight
Regulation Description	Urological catheter and accessories.
Product Code	EZD
Regulation Number	876.5130
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIG BLUE BIOTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
BONREE MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST
	SUBSTANTIALLY EQUIVALENT	6
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT	4
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT	1
CONVATEC
	SUBSTANTIALLY EQUIVALENT	2
CONVATEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU JIMUSHI MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K222677 Intermittent nelaton catheter for single use
HOLLISTER INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELLSPECT AB
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	578	578
Defective Device	555	555
Improper Chemical Reaction	390	390
Sharp Edges	216	216
Difficult to Remove	161	161
Biocompatibility	151	151
Difficult to Insert	128	128
Product Quality Problem	120	120
Component Misassembled	116	116
Incorrect Measurement	104	104
Material Twisted/Bent	74	74
Material Fragmentation	55	55
Difficult to Open or Close	41	41
Inaccurate Flow Rate	40	40
Unsealed Device Packaging	40	40
Component Missing	39	39
Delivered as Unsterile Product	35	35
Contamination /Decontamination Problem	34	34
Patient-Device Incompatibility	33	33
Inadequacy of Device Shape and/or Size	32	32
Device Handling Problem	31	31
Nonstandard Device	29	29
Insufficient Information	29	29
Material Integrity Problem	27	27
Tear, Rip or Hole in Device Packaging	26	26
Patient Device Interaction Problem	24	24
Break	22	22
Manufacturing, Packaging or Shipping Problem	22	22
Material Protrusion/Extrusion	21	21
Fluid/Blood Leak	15	15
Therapeutic or Diagnostic Output Failure	13	13
Device Damaged Prior to Use	13	13
Defective Component	12	12
Use of Device Problem	11	11
Misassembled	11	11
Material Too Soft/Flexible	10	10
Short Fill	9	9
Material Too Rigid or Stiff	9	9
Scratched Material	8	8
Device Misassembled During Manufacturing /Shipping	8	8
Difficult to Open or Remove Packaging Material	8	8
Material Deformation	8	8
Material Disintegration	7	7
No Flow	7	7
Incomplete or Missing Packaging	7	7
Material Split, Cut or Torn	7	7
Physical Resistance/Sticking	6	6
Structural Problem	6	6
Leak/Splash	6	6
Partial Blockage	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1473	1473
Urinary Tract Infection	701	701
No Consequences Or Impact To Patient	282	282
Pain	191	191
No Known Impact Or Consequence To Patient	184	184
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	141	141
Hemorrhage/Bleeding	102	102
Discomfort	75	75
Unspecified Infection	62	62
Patient Problem/Medical Problem	42	42
No Patient Involvement	36	36
Abrasion	26	26
Sepsis	24	24
No Code Available	21	21
Unspecified Tissue Injury	19	19
Hematuria	13	13
Burning Sensation	12	12
Tissue Breakdown	11	11
Blood Loss	10	10
Irritation	9	9
Insufficient Information	8	16
Rash	8	8
Irritability	7	7
Genital Bleeding	7	7
Skin Inflammation/ Irritation	7	7
Skin Tears	7	7
Fever	7	7
Hypersensitivity/Allergic reaction	6	6
Laceration(s)	6	6
Injury	6	6
Foreign Body In Patient	5	5
Bacterial Infection	4	4
Bruise/Contusion	3	3
Thrombus	3	3
Headache	3	3
Local Reaction	3	3
Fungal Infection	3	3
Skin Irritation	3	3
Nausea	3	3
Erythema	2	2
Swelling	2	2
Urinary Retention	2	2
Vomiting	2	2
Swelling/ Edema	2	2
Abdominal Cramps	2	2
Dysuria	2	2
Confusion/ Disorientation	1	1
Localized Skin Lesion	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Obstruction/Occlusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Jun-08-2023
2	Wellspect HealthCare (Division of DENTSPLY IH AB)	II	Jul-17-2020