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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 587
Obstruction of Flow 37
Difficult to Advance 29
Device Handling Problem 27
Adverse Event Without Identified Device or Use Problem 23
Device Operates Differently Than Expected 20
Material Twisted / Bent 18
Detachment of Device or device Component 17
Device Damaged by Another Device 14
Human Factors Issue 12
Split 12
Catheter 12
Torn Material 10
Physical Resistance / Sticking 9
Difficult to Remove 9
Improper or Incorrect Procedure or Method 9
Retraction Problem 8
Use of Device Problem 8
Device Issue 8
Crack 8
Material Split, Cut or Torn 7
Fracture 7
Entrapment of Device 6
Positioning Problem 5
Stretched 5
Packaging Problem 4
Mechanical Problem 4
Premature Separation 4
Material Fragmentation 4
Failure To Adhere Or Bond 4
No Flow 4
Inaccurate Flow rate 3
Mechanical Jam 3
Material Rupture 3
Fluid Leak 3
Labelling, Instructions for Use or Training Problem 3
Difficult To Position 2
Device Or Device Fragments Location Unknown 2
Patient Device Interaction Problem 2
Material Separation 2
Device-Device Incompatibility 2
Leak / Splash 2
Product Quality Problem 2
Tip breakage 2
Device, or device fragments remain in patient 2
Patient-Device Incompatibility 2
Connection Problem 2
Appropriate Term/Code Not Available 1
Component Missing 1
Activation, Positioning or Separation Problem 1
Device Dislodged or Dislocated 1
Uncoiled 1
Physical Resistance 1
Device Inoperable 1
Contamination During Use 1
Peeled / Delaminated 1
Sticking 1
Failure to Infuse 1
Unsealed Device Packaging 1
Cut In Material 1
Defective Device 1
Filter 1
Nonstandard device 1
Cross Reactivity 1
Loose or Intermittent Connection 1
Manufacturing, Packaging or Shipping Problem 1
Total Device Problems 987

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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