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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
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  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

MDR Year MDR Reports MDR Events
2015 43 43
2016 71 71
2017 38 38
2018 79 79
2019 779 779
2020 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Break 713 713
Detachment of Device or Device Component 56 56
Difficult to Advance 50 50
Obstruction of Flow 42 42
Material Twisted/Bent 28 28
Device Handling Problem 27 27
Adverse Event Without Identified Device or Use Problem 27 27
Catheter 25 25
Device Operates Differently Than Expected 22 22
Fluid Leak 22 22
Failure to Advance 17 17
Physical Resistance/Sticking 15 15
Fracture 15 15
Device Damaged by Another Device 14 14
No Flow 13 13
Human Factors Issue 12 12
Difficult to Remove 11 11
Crack 10 10
Torn Material 10 10
Tip 10 10
Improper or Incorrect Procedure or Method 10 10
Stretched 9 9
Use of Device Problem 9 9
Device Issue 8 8
Retraction Problem 8 8
Material Split, Cut or Torn 8 8
Detachment Of Device Component 8 8
Loose or Intermittent Connection 8 8
Entrapment of Device 7 7
Material Fragmentation 7 7
Material Separation 6 6
Shipping Damage or Problem 5 5
Defective Device 5 5
Disconnection 5 5
Leak/Splash 5 5
Positioning Problem 5 5
Premature Separation 4 4
Product Quality Problem 4 4
Kinked 4 4
Failure To Adhere Or Bond 4 4
Device Or Device Fragments Location Unknown 4 4
Component Missing 4 4
Mechanical Problem 4 4
Packaging Problem 4 4
Split 4 4
Physical Resistance 4 4
Mechanical Jam 3 3
Appropriate Term/Code Not Available 3 3
Labelling, Instructions for Use or Training Problem 3 3
Patient-Device Incompatibility 3 3
Activation, Positioning or SeparationProblem 3 3
Device Dislodged or Dislocated 3 3
Inaccurate Flow Rate 3 3
Material Rupture 3 3
Connection Problem 3 3
Device-Device Incompatibility 2 2
Tip breakage 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Difficult to Insert 2 2
Increase in Pressure 2 2
Failure to Deliver 2 2
Device, or device fragments remain in patient 2 2
Difficult To Position 2 2
Device Slipped 2 2
Needle 2 2
Patient Device Interaction Problem 2 2
Material Puncture/Hole 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Luer Valve 1 1
Filter 1 1
Cut In Material 1 1
Structural Problem 1 1
Peeled/Delaminated 1 1
Partial Blockage 1 1
Contamination 1 1
Cross Reactivity 1 1
Connector 1 1
Coil 1 1
Lock 1 1
Shaft 1 1
Device Fell 1 1
Unraveled Material 1 1
Sticking 1 1
Defective Component 1 1
Failure to Infuse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 528 528
No Consequences Or Impact To Patient 276 276
No Information 101 101
Device Embedded In Tissue or Plaque 59 59
No Known Impact Or Consequence To Patient 50 50
Not Applicable 33 33
Foreign Body In Patient 28 28
Awareness during Anaesthesia 18 18
Unspecified Infection 14 14
Pain 13 13
No Code Available 13 13
Inadequate Pain Relief 5 5
Reaction 3 3
Death 3 3
Patient Problem/Medical Problem 3 3
Swelling 3 3
Pregnancy 2 2
Other (for use when an appropriate patient code cannot be identified) 2 2
Toxicity 2 2
Fever 2 2
Purulent Discharge 2 2
Bacterial Infection 2 2
Cardiac Arrest 2 2
Local Reaction 2 2
Tissue Damage 2 2
Hemothorax 2 2
Injury 2 2
Nausea 1 1
Post Operative Wound Infection 1 1
Alteration In Body Temperature 1 1
Dizziness 1 1
Anxiety 1 1
Discomfort 1 1
Cellulitis 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Rash 1 1
Burn(s) 1 1
Cardiopulmonary Arrest 1 1
Erythema 1 1
Sedation 1 1
Decreased Respiratory Rate 1 1
Underdose 1 1
Wound Dehiscence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Jun-05-2020
2 Arrow International Inc II Feb-14-2020
3 Arrow International Inc II Jan-24-2020
4 B. Braun Medical, Inc. II Oct-01-2018
5 Epimed International, Inc. II Jul-24-2019
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