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	1280
2023	1162	1162
2024	1262	1262
2025	691	691

Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	857	857
Improper Chemical Reaction	462	462
Adverse Event Without Identified Device or Use Problem	440	440
Difficult to Remove	436	436
Material Twisted/Bent	353	353
Device Misassembled During Manufacturing /Shipping	346	346
Material Rupture	338	338
Component Misassembled	324	324
Material Puncture/Hole	273	273
Decrease in Pressure	255	255
Deflation Problem	253	253
Sharp Edges	226	226
Incorrect Measurement	202	202
Fluid/Blood Leak	200	200
Difficult to Insert	189	189
Tear, Rip or Hole in Device Packaging	157	157
Partial Blockage	156	156
Short Fill	154	154
Nonstandard Device	136	136
Component Missing	128	128
Biocompatibility	121	121
Contamination /Decontamination Problem	111	111
Material Fragmentation	106	106
Inaccurate Flow Rate	104	104
Failure to Infuse	95	95
Material Split, Cut or Torn	94	94
Leak/Splash	75	75
Unsealed Device Packaging	72	72
Patient Device Interaction Problem	72	72
Material Too Rigid or Stiff	68	68
Device Handling Problem	65	65
Break	62	62
Product Quality Problem	60	60
Material Protrusion/Extrusion	55	55
Difficult to Open or Remove Packaging Material	52	52
Inflation Problem	47	47
Device Contamination with Chemical or Other Material	46	46
Unintended Deflation	43	43
Inability to Irrigate	42	42
Device Slipped	42	42
Inadequacy of Device Shape and/or Size	38	38
Deformation Due to Compressive Stress	35	35
Defective Device	35	35
Device Fell	34	34
Device Contaminated During Manufacture or Shipping	34	34
Incomplete or Missing Packaging	34	34
Material Separation	32	32
Failure to Deflate	31	31
Naturally Worn	29	29
Material Deformation	26	26

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4542	4542
No Consequences Or Impact To Patient	807	807
No Known Impact Or Consequence To Patient	469	469
Pain	460	460
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	451	451
Urinary Tract Infection	442	442
Discomfort	186	186
No Patient Involvement	181	181
Hemorrhage/Bleeding	101	101
Patient Problem/Medical Problem	93	93
Hematuria	87	87
Insufficient Information	68	68
Foreign Body In Patient	66	66
Blood Loss	63	63
Unspecified Tissue Injury	62	62
Unspecified Infection	55	55
Bacterial Infection	52	52
No Code Available	49	49
Urinary Retention	37	37
Sepsis	29	29
Abdominal Distention	28	28
Skin Inflammation/ Irritation	28	28
Tissue Breakdown	25	25
Swelling/ Edema	16	16
Perforation	16	16
Abrasion	15	15
Abdominal Pain	15	15
Exposure to Body Fluids	13	13
Bruise/Contusion	13	13
Irritability	12	12
Fever	11	11
Fistula	11	11
Incontinence	11	11
Irritation	11	11
Skin Discoloration	10	10
Burning Sensation	10	10
Obstruction/Occlusion	10	10
Inflammation	10	10
Laceration(s)	10	10
Dysuria	9	9
Micturition Urgency	8	8
Injury	8	8
Genital Bleeding	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Urinary Incontinence	7	7
Hematoma	7	7
Septic Shock	7	7
Cancer	7	7
Low Blood Pressure/ Hypotension	6	6
Unspecified Gastrointestinal Problem	6	6

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