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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device tray, catheterization, sterile urethral, with or without catheter (kit)
Product CodeFCM
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 79 79
2020 86 86
2021 85 85
2022 59 59
2023 48 48
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 45 45
Improper Chemical Reaction 41 41
Component Misassembled 31 31
Difficult to Insert 30 30
Product Quality Problem 23 23
Material Twisted/Bent 20 20
Fluid/Blood Leak 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Biocompatibility 18 18
Nonstandard Device 16 16
Inaccurate Flow Rate 13 13
Unintended Deflation 13 13
Incorrect Measurement 12 12
Patient-Device Incompatibility 11 11
Defective Device 9 9
Misassembled 9 9
Deflation Problem 8 8
Material Integrity Problem 8 8
Deformation Due to Compressive Stress 7 7
Material Fragmentation 7 7
Gel Leak 7 7
Material Rupture 7 7
Leak/Splash 6 6
Detachment of Device or Device Component 6 6
Material Deformation 6 6
Sharp Edges 6 6
No Flow 5 5
Partial Blockage 5 5
Break 4 4
Inadequacy of Device Shape and/or Size 4 4
Contamination /Decontamination Problem 4 4
Structural Problem 4 4
Tear, Rip or Hole in Device Packaging 3 3
Therapeutic or Diagnostic Output Failure 3 3
Insufficient Information 3 3
Shipping Damage or Problem 3 3
Burst Container or Vessel 3 3
Disconnection 3 3
Premature Separation 3 3
Material Split, Cut or Torn 3 3
Inadequate Lubrication 3 3
Failure to Deflate 3 3
Improper or Incorrect Procedure or Method 2 2
Difficult to Remove 2 2
Unsealed Device Packaging 2 2
Material Protrusion/Extrusion 2 2
Packaging Problem 2 2
Obstruction of Flow 2 2
Defective Component 2 2
Device Dislodged or Dislocated 2 2
Infusion or Flow Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Incomplete or Missing Packaging 1 1
Fungus in Device Environment 1 1
Positioning Problem 1 1
Scratched Material 1 1
Moisture or Humidity Problem 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Material Too Soft/Flexible 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Material Puncture/Hole 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 1
Suction Problem 1 1
Use of Device Problem 1 1
Short Fill 1 1
Material Separation 1 1
Restricted Flow rate 1 1
Material Discolored 1 1
Complete Blockage 1 1
Loose or Intermittent Connection 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Inflation Problem 1 1
Fracture 1 1
Physical Resistance/Sticking 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 193 193
No Consequences Or Impact To Patient 84 84
No Known Impact Or Consequence To Patient 81 81
Urinary Tract Infection 38 38
No Patient Involvement 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Pain 10 10
Hemorrhage/Bleeding 8 8
Patient Problem/Medical Problem 8 8
Insufficient Information 7 7
Discomfort 6 6
Blood Loss 5 5
Foreign Body In Patient 5 5
No Code Available 5 5
Unspecified Infection 3 3
Abrasion 2 2
Sepsis 2 2
Tissue Damage 2 2
Tissue Breakdown 2 2
Hematuria 2 2
Skin Inflammation/ Irritation 1 1
Urinary Incontinence 1 1
Urinary Retention 1 1
Pressure Sores 1 1
Distress 1 1
Injury 1 1
Irritability 1 1
Skin Tears 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Failure of Implant 1 1
Nausea 1 1
Staphylococcus Aureus 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 Aug-03-2023
4 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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