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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 , INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 71 71
2017 38 38
2018 80 80
2019 779 779
2020 159 159
2021 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Break 719 719
Detachment of Device or Device Component 63 63
Obstruction of Flow 54 54
Difficult to Advance 50 50
Fluid Leak 29 29
Material Twisted/Bent 28 28
Device Handling Problem 28 28
Device Operates Differently Than Expected 22 22
Adverse Event Without Identified Device or Use Problem 21 21
Failure to Advance 20 20
No Flow 20 20
Physical Resistance/Sticking 16 16
Device Damaged by Another Device 15 15
Fracture 15 15
Difficult to Remove 12 12
Human Factors Issue 12 12
Material Split, Cut or Torn 11 11
Crack 10 10
Improper or Incorrect Procedure or Method 10 10
Loose or Intermittent Connection 8 8
Material Fragmentation 8 8
Retraction Problem 8 8
Device Issue 8 8
Material Separation 7 7
Leak/Splash 7 7
Detachment Of Device Component 7 7
Entrapment of Device 6 6
Use of Device Problem 6 6
Component Missing 5 5
Shipping Damage or Problem 5 5
Stretched 5 5
Defective Device 5 5
Disconnection 5 5
Kinked 4 4
Failure To Adhere Or Bond 4 4
Product Quality Problem 4 4
Premature Separation 4 4
Mechanical Problem 4 4
Packaging Problem 4 4
Appropriate Term/Code Not Available 3 3
Labelling, Instructions for Use or Training Problem 3 3
Device Or Device Fragments Location Unknown 3 3
Patient-Device Incompatibility 3 3
Activation, Positioning or SeparationProblem 3 3
Physical Resistance 3 3
Mechanical Jam 3 3
Device Dislodged or Dislocated 3 3
Connection Problem 3 3
Material Rupture 3 3
Increase in Pressure 2 2
Device-Device Incompatibility 2 2
Positioning Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Device Slipped 2 2
Failure to Deliver 2 2
Difficult To Position 2 2
Torn Material 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
Structural Problem 1 1
Defective Component 1 1
Failure to Infuse 1 1
Device Fell 1 1
Peeled/Delaminated 1 1
Sticking 1 1
Unraveled Material 1 1
Partial Blockage 1 1
Contamination 1 1
Cross Reactivity 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 528 528
No Consequences Or Impact To Patient 291 291
No Information 95 95
No Known Impact Or Consequence To Patient 53 53
Device Embedded In Tissue or Plaque 38 38
No Clinical Signs, Symptoms or Conditions 34 34
Not Applicable 33 33
Foreign Body In Patient 33 33
Awareness during Anaesthesia 18 18
No Code Available 13 13
Pain 13 13
Unspecified Infection 11 11
Inadequate Pain Relief 5 5
Death 3 3
Patient Problem/Medical Problem 3 3
Swelling 3 3
Pregnancy 2 2
Insufficient Information 2 2
Toxicity 2 2
Injury 2 2
Cardiac Arrest 2 2
Hemothorax 2 2
Reaction 2 2
Local Reaction 2 2
Tissue Damage 2 2
Vomiting 1 1
Dizziness 1 1
Anxiety 1 1
Discomfort 1 1
Post Operative Wound Infection 1 1
Alteration In Body Temperature 1 1
Bacterial Infection 1 1
Nausea 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Hemorrhage/Bleeding 1 1
Sedation 1 1
Decreased Respiratory Rate 1 1
Underdose 1 1
Wound Dehiscence 1 1
Burn(s) 1 1
Cardiopulmonary Arrest 1 1
Erythema 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Rash 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 Mar-18-2021
6 Epimed International, Inc. II Jul-24-2019
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