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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
EPIMED INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 159 159
2021 146 146
2022 135 135
2023 80 80
2024 99 99
2025 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Break 166 166
Fluid/Blood Leak 56 56
Obstruction of Flow 52 52
Material Separation 50 50
No Flow 41 41
Difficult to Advance 41 41
Material Twisted/Bent 31 31
Failure to Advance 23 23
Physical Resistance/Sticking 21 21
Detachment of Device or Device Component 19 19
Adverse Event Without Identified Device or Use Problem 16 16
Material Fragmentation 16 16
Difficult to Remove 14 14
Leak/Splash 13 13
Disconnection 11 11
Material Split, Cut or Torn 10 10
Fracture 10 10
Unsealed Device Packaging 9 9
Material Integrity Problem 8 8
Stretched 7 7
Shipping Damage or Problem 5 5
Burst Container or Vessel 5 5
Complete Blockage 5 5
Material Puncture/Hole 4 4
Activation, Positioning or Separation Problem 4 4
Material Rupture 3 3
Unraveled Material 3 3
Device Damaged Prior to Use 3 3
Material Too Soft/Flexible 3 3
Defective Device 3 3
Device Dislodged or Dislocated 3 3
Premature Separation 3 3
Unintended Movement 2 2
Flushing Problem 2 2
Entrapment of Device 2 2
Separation Problem 2 2
Crack 2 2
Contamination 2 2
Gas/Air Leak 2 2
Device Markings/Labelling Problem 2 2
Mechanical Problem 2 2
Dull, Blunt 2 2
Device Contamination with Body Fluid 2 2
Defective Component 2 2
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Incomplete or Inadequate Connection 1 1
Nonstandard Device 1 1
Sharp Edges 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 345 345
Foreign Body In Patient 92 92
No Consequences Or Impact To Patient 85 85
Insufficient Information 50 50
No Patient Involvement 28 28
Device Embedded In Tissue or Plaque 16 16
Pain 15 15
Needle Stick/Puncture 12 12
No Information 6 6
Unspecified Infection 6 6
No Known Impact Or Consequence To Patient 5 5
Discomfort 4 4
Headache 4 4
Swelling/ Edema 3 3
Inadequate Pain Relief 3 3
Bacterial Infection 3 3
Embolism/Embolus 2 2
Paresthesia 2 2
Spinal Column Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hemorrhage/Bleeding 2 2
Hematoma 2 2
Cerebrospinal Fluid Leakage 2 2
Respiratory Insufficiency 1 1
Convulsion/Seizure 1 1
No Code Available 1 1
Patient Problem/Medical Problem 1 1
Decreased Sensitivity 1 1
Hypersensitivity/Allergic reaction 1 1
Fever 1 1
Dyspnea 1 1
Purulent Discharge 1 1
Cellulitis 1 1
Awareness during Anaesthesia 1 1
Abscess 1 1
Pulmonary Embolism 1 1
Low Oxygen Saturation 1 1
Fungal Infection 1 1
Distress 1 1
Unspecified Tissue Injury 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Rupture 1 1
Vomiting 1 1
Perforation of Vessels 1 1
Tachycardia 1 1
Sepsis 1 1
Perforation 1 1
Neuropathy 1 1
Muscle Weakness 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 Epimed International II Aug-18-2021
5 Epimed International, Inc. II Mar-18-2021
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