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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urinometer, mechanical
Regulation Description Urine flow or volume measuring system.
Product CodeEXR
Regulation Number 876.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Disconnection 23
Occlusion within device 18
Detachment of device component 7
No flow 7
Leak 6
Defective component 5
Device operates differently than expected 5
Infusion or flow issue 5
Unable to obtain readings 3
Restricted flowrate 3
Decoupling 3
Blockage within device or device component 3
Mechanical issue 2
Break 2
Delivered as unsterile product 2
Connection issue 2
Positioning Issue 2
No Known Device Problem 1
Free or unrestricted flow 1
Component missing 1
Improper or incorrect procedure or method 1
Other (for use when an appropriate device code cannot be identified) 1
Device damaged prior to use 1
Migration of device or device component 1
Material fragmentation 1
Loss of or failure to bond 1
Failure to deploy 1
Total Device Problems 108

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