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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 26
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
Foreign material present in device 7
Detachment of device component 7
Sediment, precipitate or deposit in device or device ingredient 7
Fracture 6
Improper flow or infusion 6
Crack 6
Material separation 5
Blockage within device or device component 4
Disconnection 4
Improper device output 4
Defective component 3
Tear, rip or hole in device packaging 3
Product quality issue 3
Measurement system incompatibility 3
Obstruction within device 3
Biofilm coating in device 3
Delivered as unsterile product 3
Connection issue 3
Collapse 3
Detachment of device or device component 2
Insufficient flow or underinfusion 2
Device packaging compromised 2
Use of Device Issue 2
Component missing 2
Difficult to open or close 1
Difficult to deploy 1
Decoupling 1
Material integrity issue 1
Contamination during use 1
Failure to deploy 1
Material fragmentation 1
Unsealed device packaging 1
Out-of-box failure 1
Item contaminated during manufacturing or shipping 1
Device Contamination with biological material 1
Device disinfection or sterilization issue 1
Positioning Issue 1
Kinked 1
Filling problem 1
Total Device Problems 282

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