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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device foley catheter kit (excludes hiv testing)
Regulation Description Urological catheter and accessories.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodePPB
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2023 17 17
2024 50 50
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 9 9
Leak/Splash 7 7
Appropriate Term/Code Not Available 6 6
Inflation Problem 6 6
Material Integrity Problem 6 6
Break 3 3
Burst Container or Vessel 3 3
Obstruction of Flow 2 2
Contamination 1 1
Connection Problem 1 1
Infusion or Flow Problem 1 1
Deflation Problem 1 1
Insufficient Information 1 1
Defective Device 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
Insufficient Information 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Dysuria 3 3
Urinary Retention 2 2
Distress 1 1
Failure of Implant 1 1
Exposure to Body Fluids 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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