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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
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2020 86 86
2021 85 86
2022 59 61
2023 48 48
2024 54 54
2025 37 37
2026 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Improper Chemical Reaction 54 54
Component Missing 34 34
Component Misassembled 34 35
Material Twisted/Bent 24 24
Difficult to Remove 22 22
Unintended Deflation 22 22
Fluid/Blood Leak 20 20
Packaging Problem 20 20
Adverse Event Without Identified Device or Use Problem 19 19
Biocompatibility 18 18
Nonstandard Device 17 17
Difficult to Insert 16 16
Inaccurate Flow Rate 11 11
Material Rupture 11 11
Material Fragmentation 11 12
Incorrect Measurement 10 10
Gel Leak 10 10
Product Quality Problem 8 8
Deformation Due to Compressive Stress 7 7
Disconnection 7 7
Detachment of Device or Device Component 6 6
Deflation Problem 6 6
Partial Blockage 6 6
Obstruction of Flow 6 6
Sharp Edges 5 5
Defective Device 4 4
Shipping Damage or Problem 4 4
Material Deformation 4 4
Break 4 4
Material Split, Cut or Torn 4 6
Material Integrity Problem 3 3
Patient-Device Incompatibility 3 3
Failure to Deflate 3 3
Premature Separation 3 3
Contamination /Decontamination Problem 3 3
Inadequate Lubrication 3 3
No Flow 3 3
Leak/Splash 3 3
Device Dislodged or Dislocated 2 2
Material Protrusion/Extrusion 2 2
Inadequacy of Device Shape and/or Size 2 2
Improper or Incorrect Procedure or Method 2 2
Infusion or Flow Problem 2 2
Use of Device Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Wrong Label 2 2
Insufficient Information 2 2
Structural Problem 1 1
Inflation Problem 1 3
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 274 277
No Consequences Or Impact To Patient 41 41
Urinary Tract Infection 38 38
No Known Impact Or Consequence To Patient 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
No Patient Involvement 15 15
Foreign Body In Patient 9 9
Insufficient Information 9 9
Patient Problem/Medical Problem 7 7
Hemorrhage/Bleeding 7 7
Pain 6 6
Unspecified Infection 5 5
No Code Available 5 5
Discomfort 4 4
Skin Inflammation/ Irritation 3 3
Sepsis 2 2
Tissue Breakdown 2 2
Failure of Implant 1 1
Nausea 1 1
Urinary Incontinence 1 1
Hematuria 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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