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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 15 15

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
Leak/Splash 37 37
Fluid/Blood Leak 36 36
Component Missing 32 32
Inflation Problem 28 28
Material Rupture 27 27
Break 25 25
Burst Container or Vessel 17 17
Adverse Event Without Identified Device or Use Problem 12 12
Detachment of Device or Device Component 10 10
Deflation Problem 9 9
Device Slipped 8 8
Device Dislodged or Dislocated 8 8
Material Split, Cut or Torn 6 6
Insufficient Information 6 6
Device Fell 6 6
Material Puncture/Hole 5 5
Obstruction of Flow 5 5
Connection Problem 4 4
Material Fragmentation 4 4
Output Problem 3 3
Component Misassembled 3 3
Infusion or Flow Problem 3 3
Failure to Deflate 2 2
Nonstandard Device 2 2
No Apparent Adverse Event 2 2
Device Contamination with Chemical or Other Material 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Separation 2 2
Shipping Damage or Problem 2 2
Difficult to Remove 2 2
Contamination 2 2
Expiration Date Error 2 2
Unintended Deflation 2 2
Short Fill 2 2
Unintended Ejection 1 1
Difficult to Insert 1 1
Material Twisted/Bent 1 1
Inaccurate Flow Rate 1 1
Insufficient Flow or Under Infusion 1 1
Structural Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Component 1 1
Partial Blockage 1 1
Incorrect Measurement 1 1
Product Quality Problem 1 1
Wrong Label 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 248 248
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 19 19
No Patient Involvement 10 10
Foreign Body In Patient 9 9
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 3 3
Unspecified Infection 2 2
Urinary Retention 2 2
Swelling/ Edema 2 2
Genital Bleeding 1 1
Skin Inflammation/ Irritation 1 1
Itching Sensation 1 1
Incontinence 1 1
Skin Discoloration 1 1
Fever 1 1
Burning Sensation 1 1
Exposure to Body Fluids 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
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