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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 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 6 6
Leak/Splash 5 5
Appropriate Term/Code Not Available 5 5
Inflation Problem 4 4
Fluid/Blood Leak 4 4
Burst Container or Vessel 3 3
Obstruction of Flow 2 2
Insufficient Information 1 1
Defective Device 1 1
Infusion or Flow Problem 1 1
Break 1 1
Contamination 1 1
Deflation Problem 1 1
Connection Problem 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Insufficient Information 12 12
Dysuria 3 3
Urinary Retention 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 Sep-11-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
4 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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