TPLC - Total Product Life Cycle

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Device	catheter, urethral
Regulation Description	Urological catheter and accessories.
Product Code	GBM
Regulation Number	876.5130
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Tear, Rip or Hole in Device Packaging	337	337
Device Misassembled During Manufacturing /Shipping	244	244
Adverse Event Without Identified Device or Use Problem	192	192
Difficult to Remove	176	177
Sharp Edges	116	116
Unsealed Device Packaging	111	111
Material Puncture/Hole	65	65
Patient Device Interaction Problem	52	52
Insufficient Device Problem Information	36	36
Biocompatibility	31	31
Material Rupture	28	28
Contamination /Decontamination Problem	27	27
Fluid/Blood Leak	26	27
Material Invagination	24	24
Delivered as Unsterile Product	22	22
Material Split, Cut or Torn	20	20
Break	20	20
Partial Blockage	17	21
Decrease in Pressure	16	16
Difficult to Insert	16	17
Device Handling Problem	15	15
Material Too Rigid or Stiff	12	12
Inaccurate Flow Rate	11	11
Difficult to Open or Remove Packaging Material	10	10
Deflation Problem	10	10
Entrapment of Device	8	8
Fracture	7	8
Component Misassembled	7	7
Inflation Problem	7	7
Leak/Splash	7	7
Burst Container or Vessel	7	7
Material Fragmentation	6	6
Failure to Infuse	6	7
Packaging Problem	6	6
Appropriate Device Problem Term/Code Not Available	6	6
Dent in Material	5	5
Defective Device	5	5
Use of Device Problem	4	4
Material Twisted/Bent	4	5
Improper Chemical Reaction	4	5
Nonstandard Device	4	5
Physical Resistance/Sticking	4	6
Device Contamination with Chemical or Other Material	4	4
Premature Separation	3	3
Activation, Positioning or Separation Problem	3	3
Illegible Information	3	3
Product Quality Problem	3	3
Fitting Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Calcified	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1129	1139
Urinary Tract Infection	252	252
Hemorrhage/Blood Loss/Bleeding	82	82
Pain	64	65
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	59	60
Unspecified Tissue Injury	54	54
Hematuria	37	37
Tissue Breakdown	27	27
Rash	27	27
Unspecified Infection	25	25
Discomfort	23	23
Sepsis	19	19
Insufficient Information	13	13
No Consequences Or Impact To Patient	6	6
Foreign Body In Patient	6	6
Bruise/Contusion	5	5
Genital Bleeding	5	5
Exposure to Body Fluids	5	5
Dysuria	4	4
Exsanguination	4	4
Burning Sensation	4	4
Kidney Infection	3	3
Swelling/ Edema	3	3
Skin Inflammation/ Irritation	3	3
Fever	2	2
Urethral Stenosis/Stricture	2	2
Local Reaction	2	2
Urinary Retention	2	2
Abrasion	2	3
Fall	2	2
Laceration(s)	2	2
Perforation	2	2
Unspecified Kidney or Urinary Problem	2	2
Skin Tears	2	2
Fungal Infection	2	2
Hypersensitivity/Allergic reaction	2	2
Abdominal Pain	2	2
Cramp(s) /Muscle Spasm(s)	1	1
Localized Skin Lesion	1	1
Urinary Frequency / Polyuria	1	1
Itching Sensation	1	1
Purulent Discharge	1	1
Uremia	1	1
Abdominal Distention	1	1
Depression	1	1
Hematoma	1	1
Pressure Sore/Ulcer	1	1
Fluid Discharge	1	1
Urolithiasis	1	1
Renal Failure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Sep-23-2021
2	Cardinal Health 200, LLC	I	Feb-16-2024
3	HANGZHOU BEVER MEDICAL DEVICES CO., LTD.	II	Jan-12-2026
4	Hollister Ulc	II	Aug-21-2026