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U.S. Department of Health and Human Services

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 CodeOHR
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2021 48 48
2022 167 175
2023 144 144
2024 162 163
2025 152 152
2026 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 92 92
Material Integrity Problem 85 85
Appropriate Term/Code Not Available 84 84
Fluid/Blood Leak 55 55
Leak/Splash 52 53
Material Rupture 46 54
Inflation Problem 39 41
Break 33 33
Component Missing 32 32
Obstruction of Flow 19 19
Burst Container or Vessel 18 18
Detachment of Device or Device Component 18 18
Unintended Deflation 15 15
Connection Problem 13 13
Device Dislodged or Dislocated 12 12
Material Split, Cut or Torn 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Material Puncture/Hole 10 10
Insufficient Information 10 10
Deflation Problem 10 10
Device Slipped 7 9
Contamination 7 7
Failure to Deflate 6 6
Device Contamination with Body Fluid 6 6
Component Misassembled 6 6
Device Fell 6 6
Infusion or Flow Problem 5 5
Disconnection 4 4
Material Fragmentation 4 4
Mechanical Problem 4 4
Crack 4 4
Physical Resistance/Sticking 4 4
Material Separation 4 4
Air/Gas in Device 3 3
Short Fill 3 3
No Apparent Adverse Event 3 3
Output Problem 3 3
Expiration Date Error 2 2
Contamination /Decontamination Problem 2 2
Shipping Damage or Problem 2 2
Nonstandard Device 2 2
Gel Leak 2 2
Migration 2 2
Device Contamination with Chemical or Other Material 2 2
Loss of or Failure to Bond 1 1
Loose or Intermittent Connection 1 1
Fitting Problem 1 1
Material Too Soft/Flexible 1 1
Activation, Positioning or Separation Problem 1 1
Coagulation in Device or Device Ingredient 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 354 355
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 114 114
Pain 78 78
Insufficient Information 71 79
Unspecified Tissue Injury 33 33
Urinary Tract Infection 16 16
Foreign Body In Patient 12 12
Urinary Retention 12 12
Discomfort 6 6
Swelling/ Edema 6 6
Urinary Incontinence 5 5
Hemorrhage/Bleeding 5 5
Genital Bleeding 4 4
No Patient Involvement 4 4
Unspecified Infection 3 3
Unintended Extubation 3 3
Burning Sensation 2 2
Skin Inflammation/ Irritation 1 1
Itching Sensation 1 1
Chemical Exposure 1 1
Skin Discoloration 1 1
Incontinence 1 1
Unspecified Blood or Lymphatic problem 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 Nov-14-2025
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