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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tray, catheterization, sterile urethral, with or without catheter (kit)
Regulation Description Urological catheter and accessories.
Product CodeFCM
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 86 86
2021 85 85
2022 59 59
2023 48 48
2024 54 54
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Improper Chemical Reaction 48 48
Component Missing 33 33
Component Misassembled 32 32
Material Twisted/Bent 21 21
Biocompatibility 18 18
Unintended Deflation 18 18
Adverse Event Without Identified Device or Use Problem 18 18
Difficult to Insert 16 16
Fluid/Blood Leak 14 14
Nonstandard Device 14 14
Material Rupture 11 11
Inaccurate Flow Rate 9 9
Product Quality Problem 8 8
Incorrect Measurement 8 8
Deformation Due to Compressive Stress 7 7
Material Fragmentation 7 7
Partial Blockage 6 6
Obstruction of Flow 6 6
Deflation Problem 6 6
Detachment of Device or Device Component 5 5
Sharp Edges 5 5
Gel Leak 4 4
Material Deformation 4 4
Defective Device 4 4
Shipping Damage or Problem 4 4
No Flow 3 3
Premature Separation 3 3
Failure to Deflate 3 3
Disconnection 3 3
Contamination /Decontamination Problem 3 3
Material Split, Cut or Torn 3 3
Material Integrity Problem 3 3
Break 3 3
Inadequate Lubrication 3 3
Patient-Device Incompatibility 3 3
Leak/Splash 2 2
Difficult to Remove 2 2
Improper or Incorrect Procedure or Method 2 2
Therapeutic or Diagnostic Output Failure 2 2
Infusion or Flow Problem 2 2
Wrong Label 2 2
Insufficient Information 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Dislodged or Dislocated 2 2
Material Protrusion/Extrusion 2 2
Device Ingredient or Reagent Problem 1 1
Loose or Intermittent Connection 1 1
Burst Container or Vessel 1 1
Physical Resistance/Sticking 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 218 218
No Consequences Or Impact To Patient 41 41
Urinary Tract Infection 35 35
No Known Impact Or Consequence To Patient 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
No Patient Involvement 15 15
Insufficient Information 8 8
Patient Problem/Medical Problem 7 7
Hemorrhage/Bleeding 7 7
Pain 6 6
No Code Available 5 5
Foreign Body In Patient 5 5
Discomfort 4 4
Unspecified Infection 3 3
Sepsis 2 2
Tissue Breakdown 2 2
Failure of Implant 1 1
Nausea 1 1
Urinary Incontinence 1 1
Hematuria 1 1
Skin Inflammation/ Irritation 1 1
Abrasion 1 1
Blood Loss 1 1
Staphylococcus Aureus 1 1
Burn(s) 1 1
Exposure to Body Fluids 1 1
Urinary Retention 1 1
Skin Tears 1 1
Pressure Sores 1 1
Irritability 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Dec-02-2022
2 Cardinal Health 200, LLC I Feb-16-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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