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
Material Integrity Problem	81	81
Appropriate Term/Code Not Available	79	79
Fluid/Blood Leak	47	47
Leak/Splash	47	57
Material Rupture	38	46
Component Missing	36	36
Inflation Problem	35	46
Break	31	31
Burst Container or Vessel	18	18
Detachment of Device or Device Component	18	18
Obstruction of Flow	13	13
Adverse Event Without Identified Device or Use Problem	12	12
Material Split, Cut or Torn	9	9
Insufficient Information	9	9
Deflation Problem	9	18
Device Slipped	8	10
Connection Problem	8	8
Device Dislodged or Dislocated	8	8
Material Puncture/Hole	7	7
Device Fell	6	6
Unintended Deflation	6	6
Component Misassembled	6	6
Failure to Deflate	5	5
Contamination	5	5
Mechanical Problem	4	4
Device Contamination with Body Fluid	4	4
Physical Resistance/Sticking	4	4
Material Separation	4	4
Material Fragmentation	4	4
Infusion or Flow Problem	4	4
Output Problem	3	3
Crack	3	3
Short Fill	3	3
No Apparent Adverse Event	3	3
Nonstandard Device	2	2
Gel Leak	2	2
Device Contamination with Chemical or Other Material	2	2
Tear, Rip or Hole in Device Packaging	2	2
Shipping Damage or Problem	2	2
Contamination /Decontamination Problem	2	2
Difficult to Remove	2	11
Expiration Date Error	2	2
Inaccurate Flow Rate	1	1
Insufficient Flow or Under Infusion	1	1
Material Perforation	1	1
Structural Problem	1	1
Material Twisted/Bent	1	1
Unintended Ejection	1	1
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	318	319
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	112	112
Pain	69	69
Insufficient Information	59	67
Unspecified Tissue Injury	33	33
Urinary Tract Infection	20	29
Foreign Body In Patient	13	13
No Patient Involvement	10	10
Urinary Retention	10	10
Urinary Incontinence	5	5
No Known Impact Or Consequence To Patient	5	5
No Consequences Or Impact To Patient	5	5
Discomfort	4	4
Hemorrhage/Bleeding	4	4
Unspecified Infection	3	3
Unintended Extubation	3	3
Genital Bleeding	2	2
Swelling/ Edema	2	2
Skin Inflammation/ Irritation	1	1
Itching Sensation	1	1
Chemical Exposure	1	1
Skin Discoloration	1	1
Incontinence	1	1
Fever	1	1
Burning Sensation	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	Nov-14-2025