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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)
Product CodeFCM
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 5 5
2016 14 14
2017 33 33
2018 61 61
2019 79 79
2020 86 86
2021 85 85
2022 59 59
2023 48 48
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 69 69
Product Quality Problem 48 48
Improper Chemical Reaction 40 40
Difficult to Insert 39 39
Component Misassembled 30 30
Adverse Event Without Identified Device or Use Problem 23 23
Fluid/Blood Leak 23 23
Patient-Device Incompatibility 21 21
Material Twisted/Bent 21 21
Biocompatibility 18 18
Inaccurate Flow Rate 18 18
Nonstandard Device 17 17
Incorrect Measurement 17 17
Material Integrity Problem 15 15
Leak/Splash 13 13
Unintended Deflation 13 13
Deflation Problem 12 12
Defective Device 12 12
Material Deformation 10 10
Misassembled 10 10
No Flow 10 10
Device Operates Differently Than Expected 9 9
Deformation Due to Compressive Stress 8 8
Partial Blockage 8 8
Gel Leak 8 8
Material Fragmentation 7 7
Detachment of Device or Device Component 6 6
Sharp Edges 6 6
Contamination /Decontamination Problem 5 5
Material Rupture 5 5
Bent 5 5
Break 5 5
Inadequacy of Device Shape and/or Size 4 4
Structural Problem 4 4
Insufficient Information 4 4
Appropriate Term/Code Not Available 3 3
Therapeutic or Diagnostic Output Failure 3 3
Moisture or Humidity Problem 3 3
Premature Separation 3 3
Material Split, Cut or Torn 3 3
Inadequate Lubrication 3 3
Failure to Deflate 3 3
Shipping Damage or Problem 3 3
Short Fill 3 3
Defective Component 3 3
Tear, Rip or Hole in Device Packaging 3 3
Obstruction of Flow 3 3
Burst Container or Vessel 3 3
Disconnection 3 3
Difficult to Remove 3 3
Kinked 3 3
Loose or Intermittent Connection 2 2
Unsealed Device Packaging 2 2
Restricted Flow rate 2 2
Complete Blockage 2 2
Incomplete or Missing Packaging 2 2
Device Damaged Prior to Use 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Material Protrusion/Extrusion 2 2
Infusion or Flow Problem 2 2
Device Dislodged or Dislocated 2 2
Device Markings/Labelling Problem 2 2
Physical Resistance/Sticking 2 2
Scratched Material 2 2
Packaging Problem 2 2
Positioning Problem 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Material Too Soft/Flexible 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Illegible Information 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Ingredient or Reagent Problem 1 1
Device Displays Incorrect Message 1 1
Folded 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper Flow or Infusion 1 1
Suction Problem 1 1
Sticking 1 1
Device Inoperable 1 1
Fungus in Device Environment 1 1
Material Discolored 1 1
Fracture 1 1
Inflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Puncture/Hole 1 1
Delivered as Unsterile Product 1 1
Retraction Problem 1 1
Material Separation 1 1
Moisture Damage 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 189 189
No Known Impact Or Consequence To Patient 142 142
No Consequences Or Impact To Patient 122 122
Urinary Tract Infection 52 52
No Patient Involvement 45 45
Pain 17 17
Hemorrhage/Bleeding 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Patient Problem/Medical Problem 11 11
No Information 9 9
Discomfort 8 8
Insufficient Information 7 7
Foreign Body In Patient 6 6
Blood Loss 6 6
No Code Available 5 5
Tissue Damage 4 4
Unspecified Infection 4 4
Injury 3 3
Urinary Retention 2 2
Irritation 2 2
Abrasion 2 2
Sepsis 2 2
Tissue Breakdown 2 2
Skin Tears 2 2
Hematuria 2 2
Pressure Sores 1 1
Distress 1 1
Skin Inflammation/ Irritation 1 1
Urinary Incontinence 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Nausea 1 1
Staphylococcus Aureus 1 1
Burning Sensation 1 1
Reaction 1 1
Irritability 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 Customed, Inc II Mar-21-2012
4 Go Medical Industries Pty., Ltd. II Oct-21-2011
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
6 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
7 Nurse Assist, Inc II May-25-2011
8 Teleflex Medical III Aug-06-2014
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