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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, conduction, anesthetic
Regulation Description Anesthesia conduction catheter.
Product CodeBSO
Regulation Number 868.5120
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
AXIOM
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EPIMED
  SUBSTANTIALLY EQUIVALENT 3
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
I FLOW CORP
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
LIFE-TECH INT'L., INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 18
No Known Device Problem 13
Split 12
Torn material 8
Device handling issue 6
Device, or device fragments remain in patient 5
Stretched 4
Tip breakage 4
Positioning Issue 4
Improper or incorrect procedure or method 4
Use of Device Issue 3
Device or device component damaged by another device 3
Inaccurate flowrate 3
Fracture 3
Instruction for use issue 3
Leak 2
Component(s), broken 2
Entrapment of device or device component 2
Connection issue 2
No flow 2
Retraction problem 2
Material separation 2
Sticking 2
Blockage within device or device component 1
Cut in material 1
Physical resistance 1
Material integrity issue 1
Difficult to remove 1
Uncoiled 1
Device inoperable 1
Loose or intermittent connection 1
Pumping stopped 1
Product quality issue 1
Material fragmentation 1
High impedance 1
Total Device Problems 121

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 1 0 0 0
Class III 0 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 I-Flow LLC II Jun-03-2013
2 Smiths Medical ASD, Inc. III Sep-03-2009

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