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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
B. BRAUN MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
EPIMED
  SUBSTANTIALLY EQUIVALENT 1
EPIMED INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 1
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL , INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 628
Detachment of Device or device Component 49
Obstruction of Flow 38
Difficult to Advance 29
Device Handling Problem 27
Adverse Event Without Identified Device or Use Problem 24
Material Twisted / Bent 23
Device Operates Differently Than Expected 20
Device Damaged by Another Device 14
Catheter 13
Human Factors Issue 12
Split 12
Fluid Leak 11
Torn Material 10
Physical Resistance / Sticking 9
Improper or Incorrect Procedure or Method 9
Difficult to Remove 9
Material Split, Cut or Torn 8
No Flow 8
Crack 8
Use of Device Problem 8
Device Issue 8
Retraction Problem 8
Fracture 7
Entrapment of Device 6
Stretched 5
Material Fragmentation 5
Positioning Problem 5
Failure To Adhere Or Bond 4
Mechanical Problem 4
Packaging Problem 4
Failure to Advance 4
Premature Separation 4
Mechanical Jam 3
Material Rupture 3
Labelling, Instructions for Use or Training Problem 3
Inaccurate Flow rate 3
Activation, Positioning or Separation Problem 3
Device, or device fragments remain in patient 2
Connection Problem 2
Difficult To Position 2
Leak / Splash 2
Loose or Intermittent Connection 2
Patient-Device Incompatibility 2
Device-Device Incompatibility 2
Material Separation 2
Device Or Device Fragments Location Unknown 2
Patient Device Interaction Problem 2
Product Quality Problem 2
Tip breakage 2
Uncoiled 1
Peeled / Delaminated 1
Cut In Material 1
Device Dislodged or Dislocated 1
Material Deformation 1
Sticking 1
Failure to Infuse 1
Defective Device 1
Physical Resistance 1
Filter 1
Manufacturing, Packaging or Shipping Problem 1
Contamination During Use 1
Cross Reactivity 1
Disconnection 1
Nonstandard device 1
Unsealed Device Packaging 1
Device Inoperable 1
Component Missing 1
Appropriate Term/Code Not Available 1
Total Device Problems 1091

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Oct-01-2018
2 Epimed International, Inc. II Jul-24-2019

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