TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ALLWIN MEDICAL DEVICES, INC
	SUBSTANTIALLY EQUIVALENT	1
UROGEN PHARMA LTD
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	1370	1370
2021	1387	1387
2022	1280	1291
2023	1160	1160
2024	1259	1259
2025	1247	1247

Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	856	856
Adverse Event Without Identified Device or Use Problem	475	475
Improper Chemical Reaction	475	475
Difficult to Remove	446	446
Device Misassembled During Manufacturing /Shipping	439	439
Material Rupture	427	427
Material Twisted/Bent	396	396
Component Misassembled	349	349
Material Puncture/Hole	320	320
Deflation Problem	259	259
Sharp Edges	259	259
Decrease in Pressure	255	255
Fluid/Blood Leak	210	210
Incorrect Measurement	210	210
Difficult to Insert	189	189
Tear, Rip or Hole in Device Packaging	162	162
Partial Blockage	159	159
Short Fill	154	154
Nonstandard Device	137	137
Component Missing	130	130
Biocompatibility	123	123
Material Fragmentation	114	114
Contamination /Decontamination Problem	111	111
Inaccurate Flow Rate	107	107
Material Split, Cut or Torn	103	103
Failure to Infuse	95	95
Patient Device Interaction Problem	77	77
Leak/Splash	76	76
Unsealed Device Packaging	72	72
Device Handling Problem	70	70
Material Too Rigid or Stiff	68	68
Break	65	65
Product Quality Problem	61	61
Material Protrusion/Extrusion	61	61
Inflation Problem	58	58
Device Contamination with Chemical or Other Material	57	59
Difficult to Open or Remove Packaging Material	52	52
Incomplete or Missing Packaging	48	48
Unintended Deflation	47	47
Inability to Irrigate	45	45
Defective Device	42	42
Device Slipped	42	42
Complete Blockage	41	41
Deformation Due to Compressive Stress	40	40
Inadequacy of Device Shape and/or Size	38	38
Naturally Worn	38	38
Device Contaminated During Manufacture or Shipping	37	37
Device Fell	34	34
Material Separation	33	33
Failure to Deflate	31	31

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4968	4968
No Consequences Or Impact To Patient	807	807
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	482	491
Pain	480	480
Urinary Tract Infection	480	480
No Known Impact Or Consequence To Patient	469	469
Discomfort	208	208
No Patient Involvement	181	181
Hemorrhage/Bleeding	110	110
Hematuria	95	95
Patient Problem/Medical Problem	93	93
Insufficient Information	71	73
Foreign Body In Patient	69	69
Unspecified Tissue Injury	65	65
Blood Loss	63	63
Unspecified Infection	56	56
Bacterial Infection	52	52
No Code Available	49	49
Urinary Retention	37	37
Abdominal Distention	33	33
Sepsis	31	31
Skin Inflammation/ Irritation	31	31
Tissue Breakdown	25	25
Swelling/ Edema	18	18
Abrasion	17	17
Abdominal Pain	16	16
Perforation	16	16
Exposure to Body Fluids	15	15
Fever	13	13
Skin Discoloration	13	13
Bruise/Contusion	13	13
Irritability	12	12
Inflammation	11	11
Hematoma	11	11
Fistula	11	11
Obstruction/Occlusion	11	11
Incontinence	11	11
Irritation	11	11
Burning Sensation	11	11
Laceration(s)	10	10
Dysuria	10	10
Genital Bleeding	9	9
Micturition Urgency	9	9
Cramp(s) /Muscle Spasm(s)	8	8
Septic Shock	8	8
Injury	8	8
Urinary Incontinence	7	7
Low Blood Pressure/ Hypotension	7	7
Cancer	7	7
Anemia	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Jul-03-2025
2	C.R. Bard Inc	II	Feb-24-2022
3	C.R. Bard, Inc.	II	Apr-16-2021
4	Cardinal Health 200, LLC	I	Feb-16-2024
5	Covidien Llc	II	May-14-2020
6	TELEFLEX LLC	II	Nov-11-2022