TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
BONREE MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
COLOPLAST
	SUBSTANTIALLY EQUIVALENT	6
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT	5
CONVATEC
	SUBSTANTIALLY EQUIVALENT	2
CONVATEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CONVATEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU JIMUSHI MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOLLISTER INCORPORATED
	SUBSTANTIALLY EQUIVALENT	5
HR HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
JAMJOOM FULLCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELLSPECT AB
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2021	994	1003
2022	487	489
2023	553	554
2024	116	116
2025	291	291
2026	97	97

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	532	532
Adverse Event Without Identified Device or Use Problem	435	436
Improper Chemical Reaction	299	299
Sharp Edges	214	214
Difficult to Remove	156	157
Component Misassembled	96	96
Product Quality Problem	87	87
Incorrect Measurement	76	76
Biocompatibility	72	72
Difficult to Insert	68	68
Material Twisted/Bent	57	57
Material Fragmentation	54	54
Tear, Rip or Hole in Device Packaging	54	54
Unsealed Device Packaging	47	47
Delivered as Unsterile Product	45	45
Difficult to Open or Close	41	41
Device Handling Problem	37	38
Contamination /Decontamination Problem	34	34
Patient Device Interaction Problem	31	31
Inaccurate Flow Rate	30	30
Nonstandard Device	24	24
Insufficient Information	24	24
Break	21	21
Material Protrusion/Extrusion	21	21
Inadequacy of Device Shape and/or Size	12	12
Component Missing	10	10
Fluid/Blood Leak	9	9
Defective Component	8	8
Difficult to Open or Remove Packaging Material	8	8
Device Misassembled During Manufacturing /Shipping	8	8
Material Disintegration	7	7
Material Too Soft/Flexible	7	7
Incomplete or Missing Packaging	7	7
Material Integrity Problem	6	6
Short Fill	6	6
Off-Label Use	6	6
Disconnection	6	6
Patient-Device Incompatibility	5	5
Material Too Rigid or Stiff	5	5
Device Contamination with Chemical or Other Material	4	4
Illegible Information	4	4
Partial Blockage	4	4
Material Split, Cut or Torn	4	4
Packaging Problem	4	4
Device Ingredient or Reagent Problem	4	4
No Apparent Adverse Event	3	3
Material Separation	3	3
Deformation Due to Compressive Stress	3	3
Inadequate Instructions for Healthcare Professional	3	3
Physical Resistance/Sticking	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1524	1526
Urinary Tract Infection	555	557
Pain	176	176
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	150	150
Hemorrhage/Bleeding	90	90
Discomfort	68	68
Unspecified Infection	50	50
No Consequences Or Impact To Patient	36	36
Sepsis	25	25
Unspecified Tissue Injury	19	19
Abrasion	19	19
Tissue Breakdown	11	11
Hematuria	10	10
Burning Sensation	10	10
Genital Bleeding	9	9
No Patient Involvement	8	8
Foreign Body In Patient	8	8
Skin Inflammation/ Irritation	8	8
Rash	8	8
Skin Tears	8	8
No Code Available	7	7
Fever	7	7
Irritability	7	7
Bacterial Infection	5	5
Hypersensitivity/Allergic reaction	4	4
Laceration(s)	3	3
Headache	3	3
Local Reaction	3	3
Fungal Infection	3	3
Nausea	3	3
Bruise/Contusion	3	4
Anemia	2	2
Cancer	2	2
Abdominal Cramps	2	2
Inflammation	2	2
Chills	2	2
Vomiting	2	2
Dysuria	2	2
Insufficient Information	2	10
Swelling/ Edema	2	2
Dementia	1	1
Perforation of Vessels	1	1
Tachycardia	1	1
Unspecified Kidney or Urinary Problem	1	1
Scar Tissue	1	1
Kidney Infection	1	1
Dehydration	1	1
Alteration in Body Temperature	1	1
Urinary Retention	1	1
Septic Shock	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Jun-08-2023