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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 38
Break 25
Leak 25
Device operates differently than expected 20
Occlusion within device 16
Fluid leak 12
Defective item 11
Infusion or flow issue 11
Restricted flowrate 8
Device damaged prior to use 7
Detachment of device component 7
Sediment, precipitate or deposit in device or device ingredient 7
Improper flow or infusion 6
Foreign material present in device 6
Fracture 5
Crack 5
Material separation 5
Blockage within device or device component 4
Disconnection 4
Improper device output 4
Tear, rip or hole in device packaging 3
Obstruction within device 3
Measurement system incompatibility 3
Biofilm coating in device 3
Collapse 3
Product quality issue 3
Defective component 3
Connection issue 3
Detachment of device or device component 2
Component missing 2
Use of Device Issue 2
Insufficient flow or underinfusion 2
Delivered as unsterile product 2
Device packaging compromised 2
Difficult to open or close 1
Item contaminated during manufacturing or shipping 1
Material integrity issue 1
Positioning Issue 1
Unsealed device packaging 1
Out-of-box failure 1
Device Contamination with biological material 1
Device disinfection or sterilization issue 1
Decoupling 1
Difficult to deploy 1
Failure to deploy 1
Filling problem 1
Contamination during use 1
Material fragmentation 1
Kinked 1
Total Device Problems 277

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