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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
2020 22 22
2021 48 48
2022 167 167
2023 144 144
2024 162 162
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 92 92
Appropriate Term/Code Not Available 72 72
Material Integrity Problem 67 67
Fluid/Blood Leak 36 36
Leak/Splash 36 36
Component Missing 32 32
Material Rupture 27 27
Inflation Problem 26 26
Break 25 25
Burst Container or Vessel 17 17
Adverse Event Without Identified Device or Use Problem 11 11
Detachment of Device or Device Component 10 10
Deflation Problem 9 9
Device Slipped 8 8
Device Dislodged or Dislocated 8 8
Device Fell 6 6
Insufficient Information 6 6
Material Split, Cut or Torn 6 6
Obstruction of Flow 5 5
Material Puncture/Hole 5 5
Material Fragmentation 4 4
Connection Problem 4 4
Infusion or Flow Problem 3 3
Output Problem 3 3
Component Misassembled 3 3
Device Contamination with Chemical or Other Material 2 2
Failure to Deflate 2 2
Expiration Date Error 2 2
Short Fill 2 2
Tear, Rip or Hole in Device Packaging 2 2
Shipping Damage or Problem 2 2
Material Separation 2 2
Unintended Deflation 2 2
Difficult to Remove 2 2
No Apparent Adverse Event 2 2
Nonstandard Device 2 2
Unintended Movement 1 1
Coagulation in Device or Device Ingredient 1 1
Material Protrusion/Extrusion 1 1
Unintended Ejection 1 1
Product Quality Problem 1 1
Insufficient Flow or Under Infusion 1 1
Material Disintegration 1 1
Activation, Positioning or Separation Problem 1 1
Device Sensing Problem 1 1
Entrapment of Device 1 1
Fracture 1 1
Incorrect Measurement 1 1
Partial Blockage 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 244 244
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 109 109
Pain 67 67
Insufficient Information 46 46
Unspecified Tissue Injury 33 33
Urinary Tract Infection 18 18
No Patient Involvement 10 10
Foreign Body In Patient 9 9
No Known Impact Or Consequence To Patient 5 5
Urinary Incontinence 5 5
No Consequences Or Impact To Patient 5 5
Discomfort 4 4
Hemorrhage/Bleeding 3 3
Unspecified Infection 2 2
Swelling/ Edema 2 2
Urinary Retention 2 2
Tissue Breakdown 1 1
Genital Bleeding 1 1
Exposure to Body Fluids 1 1
Fever 1 1
Incontinence 1 1
Skin Inflammation/ Irritation 1 1
Itching Sensation 1 1
Skin Discoloration 1 1
Burning Sensation 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
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