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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)
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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 3 3
Inflation Problem 1 1
Leak/Splash 1 1
Defective Device 1 1
Connection Problem 1 1
Infusion or Flow Problem 1 1
Material Integrity Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 6 6
Dysuria 3 3
Failure of Implant 1 1
Exposure to Body Fluids 1 1
Urinary Retention 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
2 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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