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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
2019 79 80
2020 86 86
2021 85 86
2022 59 61
2023 48 48
2024 54 54
2025 37 37
2026 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Improper Chemical Reaction 53 53
Component Misassembled 34 35
Material Twisted/Bent 25 25
Component Missing 25 25
Difficult to Remove 22 22
Unintended Deflation 22 22
Packaging Problem 20 20
Nonstandard Device 19 19
Biocompatibility 18 18
Product Quality Problem 18 18
Fluid/Blood Leak 18 18
Incorrect Measurement 15 15
Difficult to Insert 15 15
Inaccurate Flow Rate 15 15
Gel Leak 14 14
Material Fragmentation 12 13
Adverse Event Without Identified Device or Use Problem 11 11
Material Rupture 10 10
Patient-Device Incompatibility 9 9
Misassembled 9 9
Deformation Due to Compressive Stress 7 7
Detachment of Device or Device Component 7 7
Disconnection 7 7
Sharp Edges 6 6
Complete Blockage 6 6
Partial Blockage 6 6
Deflation Problem 5 5
Device Damaged Prior to Receipt by User 4 4
Obstruction of Flow 4 4
Failure to Deflate 3 3
Premature Separation 3 3
Tear, Rip or Hole in Device Packaging 3 3
Use of Device Problem 3 3
Material Split, Cut or Torn 3 3
No Flow 3 3
Wrong Label 2 2
Leak/Splash 2 2
Infusion or Flow Problem 2 2
Contamination /Decontamination Problem 2 2
Illegible Information 1 1
Break 1 1
Burst Container or Vessel 1 1
Incomplete or Missing Packaging 1 1
Defective Component 1 1
Suction Problem 1 1
Restricted Flow rate 1 1
Fracture 1 1
Material Too Soft/Flexible 1 1
Patient Device Interaction Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 284 287
No Consequences Or Impact To Patient 84 84
No Known Impact Or Consequence To Patient 81 81
Urinary Tract Infection 45 45
No Patient Involvement 30 30
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 16 16
Foreign Body In Patient 12 12
Pain 12 12
Insufficient Information 9 9
Patient Problem/Medical Problem 8 8
Hemorrhage/Blood Loss/Bleeding 8 8
Unspecified Infection 7 8
Discomfort 6 6
No Code Available 5 5
Blood Loss 5 5
Skin Inflammation/ Irritation 3 3
Sepsis 2 2
Hematuria 2 3
Abrasion 2 3
Tissue Breakdown 2 2
Tissue Damage 2 2
Skin Tears 1 1
Failure of Implant 1 1
Injury 1 1
Burn(s) 1 1
Staphylococcus Aureus 1 1
Exposure to Body Fluids 1 1
Distress 1 1
Urinary Retention 1 1
Pressure Sore/Ulcer 1 1
Urinary Incontinence 1 1
Irritability 1 1
Nausea 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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