Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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 44 44
Component Misassembled 34 35
Difficult to Remove 22 22
Unintended Deflation 22 22
Material Twisted/Bent 21 21
Packaging Problem 20 20
Component Missing 16 16
Nonstandard Device 15 15
Fluid/Blood Leak 15 15
Adverse Event Without Identified Device or Use Problem 11 11
Material Fragmentation 11 12
Gel Leak 10 10
Difficult to Insert 10 10
Material Rupture 9 9
Biocompatibility 9 9
Incorrect Measurement 8 8
Inaccurate Flow Rate 8 8
Deformation Due to Compressive Stress 7 7
Complete Blockage 6 6
Disconnection 6 6
Partial Blockage 5 5
Obstruction of Flow 4 4
Material Split, Cut or Torn 3 3
Device Damaged Prior to Receipt by User 3 3
Premature Separation 3 3
Failure to Deflate 3 3
No Flow 3 3
Sharp Edges 2 2
Infusion or Flow Problem 2 2
Detachment of Device or Device Component 2 2
Contamination /Decontamination Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Use of Device Problem 2 2
Wrong Label 2 2
Restricted Flow rate 1 1
Burst Container or Vessel 1 1
Suction Problem 1 1
Material Protrusion/Extrusion 1 1
Illegible Information 1 1
Product Quality Problem 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Unsealed Device Packaging 1 1
Delivered as Unsterile Product 1 1
Moisture Damage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 268 271
Urinary Tract Infection 25 25
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 16 16
Foreign Body In Patient 8 8
Insufficient Information 6 6
Unspecified Infection 5 5
No Consequences Or Impact To Patient 3 3
Skin Inflammation/ Irritation 3 3
No Code Available 3 3
Pain 3 3
Discomfort 3 3
Tissue Breakdown 2 2
Skin Tears 1 1
Abrasion 1 1
Pressure Sore/Ulcer 1 1
Failure of Implant 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Nausea 1 1
Distress 1 1
Exposure to Body Fluids 1 1
Hematuria 1 1
Burn(s) 1 1
Irritability 1 1
Urinary Incontinence 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
-
-