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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device manometer, spinal-fluid
Regulation Description Spinal fluid manometer.
Product CodeFMJ
Regulation Number 880.2500
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 367
Needle, separation 152
Disengaged 9
Fail-safe design failure 6
Component(s), broken 4
Difficult or delayed activation 3
Failure to capture 2
Bent 2
Break 1
Fluid leak 1
Failure to deploy 1
Disconnection 1
Connection issue 1
Deployment issue 1
No Known Device Problem 1
Device, or device fragments remain in patient 1
Total Device Problems 553

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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