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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, nasal, oxygen
Regulation Description Nasal oxygen cannula.
Product CodeCAT
Regulation Number 868.5340
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Kinked 33
Split 25
Device Issue 21
Disconnection 19
Detachment of device component 14
Folded 12
Leak 11
Device sensing issue 10
Device handling issue 9
Connection issue 7
Break 6
Misassembled 4
Detachment of device or device component 4
Fire 3
Defective item 3
Use of Device Issue 3
Improper or incorrect procedure or method 2
Fitting problem 2
Device damaged prior to use 2
Foreign material present in device 2
Crack 2
Occlusion within device 2
Material opacification 2
Knotted 2
Hole in material 2
Material separation 2
User used incorrect product for intended use 1
Bent 1
Restricted flowrate 1
Fracture 1
Material deformation 1
Material integrity issue 1
Material Protrusion 1
Material torqued 1
Material twisted 1
No Known Device Problem 1
Therapeutic or diagnostic output failure 1
No Information 1
No code available 1
Obstruction within device 1
Cut in material 1
Device operates differently than expected 1
Blocked connection 1
Total Device Problems 221

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