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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
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 2
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXANO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES
  SUBSTANTIALLY EQUIVALENT 1
CIMPAX APS
  SUBSTANTIALLY EQUIVALENT 1
EPIMED INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
EPIMED INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FERROSAN MEDICAL DEVICES SP. Z O.O.
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
PLAN 1 HEALTH, S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL , INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K140110  FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS ...
VITAL 5
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 45 45
2015 43 43
2016 71 71
2017 38 38
2018 80 80
2019 779 779
2020 159 159
2021 146 146
2022 135 135
2023 80 80
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 811 811
Obstruction of Flow 91 91
Detachment of Device or Device Component 75 75
Fluid/Blood Leak 67 67
Difficult to Advance 65 65
No Flow 53 53
Adverse Event Without Identified Device or Use Problem 53 53
Material Twisted/Bent 47 47
Material Separation 30 30
Device Handling Problem 28 28
Physical Resistance/Sticking 27 27
Failure to Advance 25 25
Difficult to Remove 24 24
Material Fragmentation 23 23
Device Operates Differently Than Expected 22 22
Material Split, Cut or Torn 19 19
Fracture 18 18
Disconnection 17 17
Torn Material 17 17
Device Damaged by Another Device 16 16
Leak/Splash 15 15
Stretched 14 14
Split 14 14
Detachment Of Device Component 12 12
Human Factors Issue 12 12
Improper or Incorrect Procedure or Method 11 11
Entrapment of Device 10 10
Crack 10 10
Unsealed Device Packaging 10 10
Use of Device Problem 9 9
Retraction Problem 8 8
Device Issue 8 8
Loose or Intermittent Connection 8 8
Material Integrity Problem 8 8
Activation, Positioning or Separation Problem 7 7
Premature Separation 7 7
Defective Device 7 7
Component Missing 6 6
Positioning Problem 6 6
Device Dislodged or Dislocated 6 6
Connection Problem 5 5
Patient-Device Incompatibility 5 5
Product Quality Problem 5 5
Shipping Damage or Problem 5 5
Burst Container or Vessel 5 5
Failure To Adhere Or Bond 4 4
Mechanical Problem 4 4
Kinked 4 4
Material Rupture 4 4
Device Or Device Fragments Location Unknown 4 4
Physical Resistance 4 4
Packaging Problem 4 4
Appropriate Term/Code Not Available 3 3
Material Too Soft/Flexible 3 3
Material Deformation 3 3
Mechanical Jam 3 3
Failure to Deliver 3 3
Unraveled Material 3 3
Device Damaged Prior to Use 3 3
Defective Component 3 3
Labelling, Instructions for Use or Training Problem 3 3
Contamination 3 3
Inaccurate Flow Rate 3 3
Flushing Problem 2 2
Complete Blockage 2 2
Difficult to Insert 2 2
Material Puncture/Hole 2 2
Difficult To Position 2 2
Increase in Pressure 2 2
Tip breakage 2 2
Device, or device fragments remain in patient 2 2
Device Slipped 2 2
Sticking 2 2
Device Contamination with Body Fluid 2 2
Dull, Blunt 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device-Device Incompatibility 2 2
Separation Problem 2 2
Patient Device Interaction Problem 2 2
Migration 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Pressure Problem 1 1
Sharp Edges 1 1
Device Fell 1 1
Difficult to Open or Close 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Failure to Disconnect 1 1
Contamination /Decontamination Problem 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Cut In Material 1 1
Structural Problem 1 1
Uncoiled 1 1
Device Inoperable 1 1
Off-Label Use 1 1
Pumping Stopped 1 1
Peeled/Delaminated 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 528 528
No Consequences Or Impact To Patient 293 293
No Clinical Signs, Symptoms or Conditions 286 286
No Information 103 103
Foreign Body In Patient 101 101
Device Embedded In Tissue or Plaque 71 71
No Known Impact Or Consequence To Patient 63 63
Insufficient Information 43 43
Not Applicable 33 33
Unspecified Infection 31 31
Pain 24 24
Awareness during Anaesthesia 19 19
No Code Available 14 14
Inadequate Pain Relief 7 7
Needle Stick/Puncture 7 7
Erythema 6 6
Bacterial Infection 5 5
Headache 4 4
Reaction 4 4
Discomfort 4 4
Tissue Damage 3 3
Patient Problem/Medical Problem 3 3
Fever 3 3
Swelling 3 3
Death 3 3
Purulent Discharge 3 3
Swelling/ Edema 3 3
Spinal Column Injury 2 2
Cellulitis 2 2
Itching Sensation 2 2
Rash 2 2
Local Reaction 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Hemothorax 2 2
Cardiac Arrest 2 2
Skin Inflammation 2 2
Pregnancy 2 2
Embolism/Embolus 2 2
Toxicity 2 2
Injury 2 2
Other (for use when an appropriate patient code cannot be identified) 2 2
Anxiety 1 1
Distress 1 1
Sedation 1 1
Vomiting 1 1
Dizziness 1 1
Fungal Infection 1 1
Low Oxygen Saturation 1 1
Decreased Respiratory Rate 1 1
Underdose 1 1
Respiratory Insufficiency 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Unspecified Tissue Injury 1 1
Convulsion/Seizure 1 1
Post Operative Wound Infection 1 1
Alteration In Body Temperature 1 1
Test Result 1 1
Cardiopulmonary Arrest 1 1
Wound Dehiscence 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Sepsis 1 1
Tachycardia 1 1
Perforation 1 1
Muscle Weakness 1 1
Nausea 1 1
Neuropathy 1 1
Cerebrospinal Fluid Leakage 1 1
Dyspnea 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 II Aug-18-2021
6 Epimed International, Inc. II Mar-18-2021
7 Epimed International, Inc. II Jul-24-2019
8 I-Flow LLC II Jun-03-2013
9 Smiths Medical ASD, Inc. III Sep-03-2009
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