TPLC - Total Product Life Cycle

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Device	collector, urine, powered, non indwelling catheter
Regulation Description	Urine collector and accessories.
Definition	For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.
Product Code	NZU
Regulation Number	876.5250
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	474	474
Biocompatibility	444	444
Patient Device Interaction Problem	149	149
Increase in Suction	126	126
Device Handling Problem	119	119
Inadequate or Insufficient Training	112	112
Illegible Information	74	74
Fluid/Blood Leak	69	69
Overheating of Device	62	62
Decrease in Suction	47	47
Suction Failure	46	46
Malposition of Device	42	42
Missing Information	30	30
Positioning Failure	27	27
Component Missing	25	25
Patient-Device Incompatibility	22	22
Nonstandard Device	18	18
Use of Device Problem	14	14
Sharp Edges	10	10
Suction Problem	10	10
Misassembly by Users	10	10
Insufficient Information	9	9
Component Misassembled	8	8
Failure to Power Up	6	6
Device Dislodged or Dislocated	5	5
Leak/Splash	5	5
No Apparent Adverse Event	5	5
Disconnection	5	5
Intermittent Loss of Power	4	4
Loss of or Failure to Bond	4	4
Incorrect Measurement	4	4
Difficult to Remove	4	4
Fracture	3	3
Labelling, Instructions for Use or Training Problem	3	3
Inadequate Instructions for Healthcare Professional	3	3
Improper or Incorrect Procedure or Method	3	3
Appropriate Term/Code Not Available	3	3
Inadequacy of Device Shape and/or Size	3	3
Device Emits Odor	3	3
Break	2	2
Restricted Flow rate	2	2
Incomplete or Missing Packaging	2	2
Detachment of Device or Device Component	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Separation	2	2
Expiration Date Error	2	2
Inadequate Instructions for Non-Healthcare Professional	1	1
Device Contamination with Chemical or Other Material	1	1
Difficult to Advance	1	1
Device Markings/Labelling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Tract Infection	811	812
No Clinical Signs, Symptoms or Conditions	383	383
Unspecified Infection	173	173
Skin Inflammation/ Irritation	143	143
Rash	87	87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	77	77
Pain	58	58
Fungal Infection	58	58
Pressure Sores	44	44
Discomfort	37	37
Burning Sensation	31	31
Hypersensitivity/Allergic reaction	29	29
Bacterial Infection	26	26
Tissue Breakdown	24	24
Itching Sensation	22	22
Sepsis	21	21
Blister	20	20
Skin Discoloration	20	20
No Consequences Or Impact To Patient	18	18
Local Reaction	17	17
Skin Tears	17	17
Abrasion	17	17
Bruise/Contusion	14	14
Irritation	14	14
Erythema	12	12
No Code Available	11	11
Swelling/ Edema	11	11
No Known Impact Or Consequence To Patient	10	10
Hematuria	7	7
Hemorrhage/Bleeding	7	7
Patient Problem/Medical Problem	6	6
Insufficient Information	5	5
Unspecified Tissue Injury	5	5
Kidney Infection	5	5
Skin Irritation	5	5
Ulcer	5	5
Localized Skin Lesion	4	4
Abscess	4	4
Cyst(s)	3	3
Fecal Incontinence	3	3
Electric Shock	3	3
Incontinence	3	3
Irritability	3	3
Reaction	3	3
Exposure to Body Fluids	2	2
No Patient Involvement	2	2
Burn(s)	2	2
Dysuria	2	2
Death	2	2
Hematoma	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Sage Products Inc	II	Nov-21-2023