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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
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 1
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 636
Detachment of Device or device Component 49
Obstruction of Flow 38
Difficult to Advance 29
Device Handling Problem 27
Material Twisted / Bent 24
Device Operates Differently Than Expected 20
Fluid Leak 19
Device Damaged by Another Device 14
Adverse Event Without Identified Device or Use Problem 14
Catheter 13
Human Factors Issue 12
No Flow 10
Physical Resistance / Sticking 10
Improper or Incorrect Procedure or Method 9
Difficult to Remove 9
Material Split, Cut or Torn 8
Crack 8
Retraction Problem 8
Device Issue 8
Use of Device Problem 8
Fracture 7
Entrapment of Device 5
Loose or Intermittent Connection 5
Material Fragmentation 5
Torn Material 5
Failure To Adhere Or Bond 4
Positioning Problem 4
Mechanical Problem 4
Packaging Problem 4
Premature Separation 4
Failure to Advance 4
Material Rupture 3
Mechanical Jam 3
Labelling, Instructions for Use or Training Problem 3
Stretched 3
Inaccurate Flow rate 3
Activation, Positioning or Separation Problem 3
Device, or device fragments remain in patient 2
Difficult To Position 2
Device-Device Incompatibility 2
Patient-Device Incompatibility 2
Material Separation 2
Device Or Device Fragments Location Unknown 2
Patient Device Interaction Problem 2
Product Quality Problem 2
Split 2
Tip breakage 2
Peeled / Delaminated 1
Device Dislodged or Dislocated 1
Cut In Material 1
Material Deformation 1
Sticking 1
Defective Device 1
Failure to Infuse 1
Physical Resistance 1
Filter 1
Manufacturing, Packaging or Shipping Problem 1
Disconnection 1
Cross Reactivity 1
Contamination During Use 1
Component Missing 1
Unsealed Device Packaging 1
Nonstandard device 1
Appropriate Term/Code Not Available 1
Connection Problem 1
Total Device Problems 1080

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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