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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

MDR Year MDR Reports MDR Events
2017 33 33
2018 61 61
2019 79 79
2020 86 86
2021 85 85
2022 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 59 59
Product Quality Problem 45 45
Difficult to Insert 30 30
Improper Chemical Reaction 29 29
Patient-Device Incompatibility 21 21
Biocompatibility 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Fluid Leak 17 17
Material Twisted/Bent 16 16
Component Misassembled 15 15
Material Integrity Problem 14 14
Incorrect Measurement 14 14
Nonstandard Device 14 14
Inaccurate Flow Rate 12 12
Defective Device 12 12
Deflation Problem 11 11
Leak/Splash 11 11
Misassembled 9 9
Material Deformation 8 8
No Flow 8 8
Gel Leak 7 7
Material Fragmentation 6 6
Detachment of Device or Device Component 6 6
Sharp Edges 6 6
Device Operates Differently Than Expected 5 5
Deformation Due to Compressive Stress 5 5
Break 5 5
Inadequacy of Device Shape and/or Size 4 4
Contamination /Decontamination Problem 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
Obstruction of Flow 3 3
Short Fill 3 3
Defective Component 3 3
Kinked 3 3
Burst Container or Vessel 3 3
Partial Blockage 3 3
Inadequate Lubrication 3 3
Failure to Deflate 2 2
Scratched Material 2 2
Physical Resistance/Sticking 2 2
Bent 2 2
Restricted Flow rate 2 2
Loose or Intermittent Connection 2 2
Shipping Damage or Problem 2 2
Unsealed Device Packaging 2 2
Improper or Incorrect Procedure or Method 2 2
Device Damaged Prior to Use 2 2
Difficult to Remove 2 2
Incomplete or Missing Packaging 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Dislodged or Dislocated 2 2
Device Markings/Labelling Problem 2 2
Material Protrusion/Extrusion 2 2
Packaging Problem 2 2
Positioning Problem 1 1
Protective Measures Problem 1 1
No Apparent Adverse Event 1 1
Device Handling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Fungus in Device Environment 1 1
Retraction Problem 1 1
Material Rupture 1 1
Material Separation 1 1
Moisture Damage 1 1
Migration or Expulsion of Device 1 1
Use of Device Problem 1 1
Material Puncture/Hole 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Fracture 1 1
Material Discolored 1 1
Disconnection 1 1
Complete Blockage 1 1
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 133 133
No Consequences Or Impact To Patient 121 121
No Clinical Signs, Symptoms or Conditions 100 100
No Patient Involvement 44 44
Urinary Tract Infection 41 41
Hemorrhage/Bleeding 13 13
Pain 12 12
Patient Problem/Medical Problem 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Insufficient Information 6 6
Foreign Body In Patient 6 6
No Information 6 6
Blood Loss 6 6
Discomfort 6 6
No Code Available 5 5
Unspecified Infection 4 4
Tissue Damage 3 3
Irritation 2 2
Sepsis 2 2
Tissue Breakdown 2 2
Skin Tears 2 2
Hematuria 2 2
Pressure Sores 1 1
Skin Inflammation/ Irritation 1 1
Urinary Incontinence 1 1
Nausea 1 1
Staphylococcus Aureus 1 1
Hypersensitivity/Allergic reaction 1 1
Abrasion 1 1
Burn(s) 1 1
Urinary Retention 1 1
Burning Sensation 1 1
Injury 1 1
Reaction 1 1
Irritability 1 1

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