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

Premarket Reviews
Manufacturer	Decision
B. BRAUN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST
	SUBSTANTIALLY EQUIVALENT	3
CONVATEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
HAKKI MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
HANGZHOU JIMUSHI MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOLLISTER INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Tear, Rip or Hole in Device Packaging	331	331
Adverse Event Without Identified Device or Use Problem	157	157
Device Misassembled During Manufacturing /Shipping	116	116
Sharp Edges	98	98
Difficult to Remove	51	51
Delivered as Unsterile Product	44	44
Patient Device Interaction Problem	37	37
Material Puncture/Hole	35	35
Biocompatibility	34	34
Fluid/Blood Leak	29	29
Contamination /Decontamination Problem	25	25
Material Invagination	23	23
Packaging Problem	21	21
Unsealed Device Packaging	21	21
Decrease in Pressure	19	19
Break	19	19
Partial Blockage	18	18
Deflation Problem	17	17
Difficult to Open or Remove Packaging Material	17	17
Difficult to Insert	16	16
Difficult to Open or Close	16	16
Material Split, Cut or Torn	16	16
Device Handling Problem	15	15
Material Deformation	14	14
Burst Container or Vessel	13	13
Material Too Rigid or Stiff	11	11
Insufficient Information	10	10
Device Markings/Labelling Problem	10	10
Device Damaged Prior to Use	10	10
Material Rupture	10	10
Inaccurate Flow Rate	10	10
Entrapment of Device	8	8
Dent in Material	8	8
Leak/Splash	8	8
Component Misassembled	7	7
Device Contamination with Chemical or Other Material	7	7
Fracture	6	6
Defective Device	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Appropriate Term/Code Not Available	6	6
Failure to Infuse	5	5
Material Fragmentation	5	5
Material Twisted/Bent	4	4
Inflation Problem	4	4
Product Quality Problem	4	4
Use of Device Problem	3	3
Detachment of Device or Device Component	3	3
Illegible Information	3	3
Improper Chemical Reaction	3	3
Premature Separation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	700	700
Urinary Tract Infection	175	175
No Consequences Or Impact To Patient	85	85
Pain	60	60
Unspecified Tissue Injury	52	52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	51	51
Hemorrhage/Bleeding	46	46
Hematuria	33	33
Rash	27	27
No Known Impact Or Consequence To Patient	26	26
Unspecified Infection	25	25
Discomfort	21	21
Tissue Breakdown	21	21
Sepsis	19	19
No Patient Involvement	18	18
Insufficient Information	9	9
Blood Loss	8	8
Patient Problem/Medical Problem	7	7
Foreign Body In Patient	6	6
Bruise/Contusion	5	5
Burning Sensation	5	5
Injury	5	5
Genital Bleeding	5	5
Exsanguination	4	4
Skin Inflammation/ Irritation	3	3
Irritation	3	3
Exposure to Body Fluids	3	3
No Code Available	3	3
Kidney Infection	2	2
Local Reaction	2	2
Urethral Stenosis/Stricture	2	2
Distress	2	2
Perforation	2	2
Fever	2	2
Fungal Infection	2	2
Fall	2	2
Laceration(s)	2	2
Cancer	2	2
Hypersensitivity/Allergic reaction	2	2
Swelling/ Edema	2	2
Skin Tears	2	2
Abdominal Pain	2	2
Loss of consciousness	1	1
Fistula	1	1
Pressure Sores	1	1
Urinary Frequency	1	1
Fainting	1	1
Device Embedded In Tissue or Plaque	1	1
Bacterial Infection	1	1
Renal Failure	1	1