TPLC - Total Product Life Cycle

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Device	catheter care tray
Regulation Description	Urological catheter and accessories.
Definition	This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product Code	OHR
Regulation Number	876.5130
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Sharp Edges	92	92
Appropriate Device Problem Term/Code Not Available	85	85
Material Integrity Problem	85	85
Fluid/Blood Leak	57	57
Leak/Splash	50	51
Inflation Problem	35	35
Component Missing	32	32
Break	29	29
Material Rupture	24	24
Obstruction of Flow	24	24
Burst Container or Vessel	15	15
Detachment of Device or Device Component	14	14
Unintended Deflation	14	14
Material Puncture/Hole	13	13
Connection Problem	12	12
Material Split, Cut or Torn	12	12
Deflation Problem	12	12
Insufficient Device Problem Information	12	12
Adverse Event Without Identified Device or Use Problem	10	10
Failure to Deflate	7	7
Contamination	7	7
Device Contamination with Body Fluid	6	6
Component Misassembled	6	6
Infusion or Flow Problem	6	6
Device Dislodged or Dislocated	5	5
Mechanical Problem	4	4
Crack	4	4
Device Sensing Problem	4	4
No Apparent Adverse Event	3	3
Material Separation	3	3
Material Fragmentation	3	3
Air/Gas in Device	3	3
Short Fill	3	3
Physical Resistance/Sticking	3	3
Disconnection	3	3
Contamination /Decontamination Problem	2	2
Expiration Date Error	2	2
Device Damaged Prior to Receipt by User	2	2
Device Contamination with Chemical or Other Material	2	2
Migration	2	2
Fracture	2	2
Gel Leak	2	2
Nonstandard Device	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Material Too Rigid or Stiff	1	1
Material Twisted/Bent	1	1
Patient Device Interaction Problem	1	1
Inaccurate Flow Rate	1	1
Difficult to Remove	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	374	375
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	115	115
Insufficient Information	93	101
Pain	79	79
Unspecified Tissue Injury	33	33
Urinary Tract Infection	17	17
Foreign Body In Patient	14	14
Urinary Retention	12	12
Hemorrhage/Blood Loss/Bleeding	9	9
Discomfort	6	6
Swelling/ Edema	6	6
Urinary Incontinence	5	5
Genital Bleeding	4	4
No Patient Involvement	4	4
Unspecified Infection	3	3
Unintended Extubation	3	3
Burning Sensation	2	2
Fungal Infection	1	1
Hematuria	1	1
Skin Inflammation/ Irritation	1	1
Pelvic Pain	1	1
Itching Sensation	1	1
Chemical Exposure	1	1
Incontinence	1	1
Skin Discoloration	1	1
Unspecified Blood or Lymphatic problem	1	1
High White Blood Cell Count	1	1
Fever	1	1
Exposure to Body Fluids	1	1
Laceration(s)	1	1
Bacterial Infection	1	1
Tissue Breakdown	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Dec-05-2024
2	MEDLINE INDUSTRIES, LP - Northfield	II	Oct-23-2024
3	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
4	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
5	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
6	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
7	Medline Industries, LP	II	Jun-17-2026
8	Medline Industries, LP	II	Nov-14-2025