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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, urine flow rate measuring, non-electrical, disposable
Regulation Description Urine flow or volume measuring system.
Product CodeFFG
Regulation Number 876.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No flow 32
Break 20
Device operates differently than expected 20
Occlusion within device 16
Leak 14
Defective item 11
Infusion or flow issue 11
Fluid leak 9
Restricted flowrate 8
Device damaged prior to use 7
Foreign material present in device 6
Improper flow or infusion 6
Sediment, precipitate or deposit in device or device ingredient 5
Fracture 5
Detachment of device component 5
Crack 5
Blockage within device or device component 4
Improper device output 4
Connection issue 3
Defective component 3
Product quality issue 3
Disconnection 3
Measurement system incompatibility 3
Material separation 2
Use of Device Issue 2
Insufficient flow or underinfusion 2
Component missing 2
Detachment of device or device component 2
Device packaging compromised 2
Difficult to open or close 1
Device Contamination with biological material 1
Device disinfection or sterilization issue 1
Out-of-box failure 1
Obstruction within device 1
Filling problem 1
Biofilm coating in device 1
Decoupling 1
Difficult to deploy 1
Failure to deploy 1
Material fragmentation 1
Kinked 1
Delivered as unsterile product 1
Unsealed device packaging 1
Total Device Problems 229

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