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
Adverse Event Without Identified Device or Use Problem	180	180
Device Misassembled During Manufacturing /Shipping	122	122
Sharp Edges	111	111
Unsealed Device Packaging	101	101
Material Puncture/Hole	55	55
Difficult to Remove	52	53
Patient Device Interaction Problem	51	51
Insufficient Information	34	34
Biocompatibility	31	31
Contamination /Decontamination Problem	27	27
Material Rupture	26	26
Fluid/Blood Leak	26	27
Material Invagination	22	22
Delivered as Unsterile Product	22	22
Break	21	21
Material Split, Cut or Torn	18	18
Partial Blockage	17	21
Difficult to Insert	17	18
Decrease in Pressure	16	16
Device Handling Problem	15	15
Material Too Rigid or Stiff	12	12
Deflation Problem	11	11
Inaccurate Flow Rate	11	11
Leak/Splash	9	9
Burst Container or Vessel	7	7
Component Misassembled	7	7
Entrapment of Device	7	7
Failure to Infuse	6	7
Fracture	6	7
Appropriate Term/Code Not Available	6	6
Dent in Material	5	5
Defective Device	5	5
Inflation Problem	5	5
Material Fragmentation	5	5
Product Quality Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Improper Chemical Reaction	4	5
Material Twisted/Bent	4	5
Activation, Positioning or Separation Problem	3	3
Illegible Information	3	3
Premature Separation	3	3
Physical Resistance/Sticking	3	5
Component Missing	2	2
Use of Device Problem	2	2
Inadequate or Insufficient Training	2	2
Calcified	2	2
Wrong Label	2	2
Complete Blockage	2	2
Device Contaminated During Manufacture or Shipping	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	861	871
Urinary Tract Infection	234	234
Pain	60	61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	54	55
Hemorrhage/Bleeding	52	52
Unspecified Tissue Injury	52	52
Hematuria	34	34
Rash	27	27
Unspecified Infection	25	25
Tissue Breakdown	25	25
Discomfort	21	21
Sepsis	19	19
Insufficient Information	13	13
No Consequences Or Impact To Patient	6	6
Bruise/Contusion	5	5
Genital Bleeding	5	5
Exposure to Body Fluids	5	5
Foreign Body In Patient	5	5
Exsanguination	4	4
Burning Sensation	4	4
Kidney Infection	3	3
Dysuria	3	3
Skin Inflammation/ Irritation	3	3
Swelling/ Edema	3	3
Skin Tears	2	2
Unspecified Kidney or Urinary Problem	2	2
Fall	2	2
Laceration(s)	2	2
Fever	2	2
Urethral Stenosis/Stricture	2	2
Local Reaction	2	2
Perforation	2	2
Fungal Infection	2	2
Hypersensitivity/Allergic reaction	2	2
Abdominal Pain	2	2
Uremia	1	1
Purulent Discharge	1	1
Urinary Retention	1	1
Abrasion	1	2
Depression	1	1
Localized Skin Lesion	1	1
Itching Sensation	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Fluid Discharge	1	1
Renal Failure	1	1
Abdominal Distention	1	1
Hematoma	1	1
No Code Available	1	1
Cancer	1	1
Bacterial Infection	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