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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
CIMPAX APS
  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
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
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 146 146
2022 135 135
2023 80 80
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Break 791 791
Obstruction of Flow 90 90
Detachment of Device or Device Component 73 73
Difficult to Advance 65 65
Fluid/Blood Leak 65 65
No Flow 50 50
Material Twisted/Bent 41 41
Adverse Event Without Identified Device or Use Problem 30 30
Device Handling Problem 28 28
Physical Resistance/Sticking 27 27
Failure to Advance 25 25
Material Separation 24 24
Device Operates Differently Than Expected 22 22
Material Fragmentation 22 22
Difficult to Remove 22 22
Material Split, Cut or Torn 19 19
Fracture 17 17
Disconnection 15 15
Device Damaged by Another Device 15 15
Leak/Splash 12 12
Human Factors Issue 12 12
Unsealed Device Packaging 10 10
Crack 10 10
Improper or Incorrect Procedure or Method 10 10
Device Issue 8 8
Loose or Intermittent Connection 8 8
Retraction Problem 8 8
Detachment Of Device Component 7 7
Entrapment of Device 7 7
Stretched 7 7
Activation, Positioning or Separation Problem 7 7
Defective Device 7 7
Material Integrity Problem 7 7
Premature Separation 7 7
Use of Device Problem 6 6
Shipping Damage or Problem 5 5
Component Missing 5 5
Burst Container or Vessel 5 5
Product Quality Problem 5 5
Material Rupture 4 4
Mechanical Problem 4 4
Kinked 4 4
Failure To Adhere Or Bond 4 4
Patient-Device Incompatibility 4 4
Device Dislodged or Dislocated 4 4
Packaging Problem 4 4
Appropriate Term/Code Not Available 3 3
Material Deformation 3 3
Mechanical Jam 3 3
Material Too Soft/Flexible 3 3
Device Or Device Fragments Location Unknown 3 3
Physical Resistance 3 3
Connection Problem 3 3
Failure to Deliver 3 3
Device Damaged Prior to Use 3 3
Contamination 3 3
Labelling, Instructions for Use or Training Problem 3 3
Material Puncture/Hole 2 2
Difficult To Position 2 2
Increase in Pressure 2 2
Complete Blockage 2 2
Flushing Problem 2 2
Unraveled Material 2 2
Device Slipped 2 2
Device Contamination with Body Fluid 2 2
Device-Device Incompatibility 2 2
Separation Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Torn Material 2 2
Patient Device Interaction Problem 2 2
Positioning Problem 2 2
Pressure Problem 1 1
Migration 1 1
Device Contamination with Chemical or Other Material 1 1
Sharp Edges 1 1
Device Fell 1 1
Difficult to Open or Close 1 1
Device Markings/Labelling Problem 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
Dull, Blunt 1 1
Structural Problem 1 1
Sticking 1 1
Defective Component 1 1
Difficult to Insert 1 1
Difficult to Flush 1 1
Partial Blockage 1 1
Corroded 1 1
Cross Reactivity 1 1
Positioning Failure 1 1
Off-Label Use 1 1
Pumping Stopped 1 1
Peeled/Delaminated 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Device Emits Odor 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 Clinical Signs, Symptoms or Conditions 273 273
No Information 95 95
Foreign Body In Patient 89 89
No Known Impact Or Consequence To Patient 53 53
Device Embedded In Tissue or Plaque 44 44
Insufficient Information 40 40
Not Applicable 33 33
Pain 19 19
Awareness during Anaesthesia 19 19
No Code Available 13 13
Unspecified Infection 11 11
Needle Stick/Puncture 7 7
Inadequate Pain Relief 7 7
Discomfort 4 4
Bacterial Infection 4 4
Headache 4 4
Death 3 3
Swelling 3 3
Patient Problem/Medical Problem 3 3
Swelling/ Edema 3 3
Pregnancy 2 2
Embolism/Embolus 2 2
Toxicity 2 2
Injury 2 2
Reaction 2 2
Fever 2 2
Spinal Column Injury 2 2
Tissue Damage 2 2
Local Reaction 2 2
Purulent Discharge 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Hemothorax 2 2
Cardiac Arrest 2 2
Cellulitis 2 2
Cerebrospinal Fluid Leakage 1 1
Cardiopulmonary Arrest 1 1
Burn(s) 1 1
Wound Dehiscence 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Dyspnea 1 1
Erythema 1 1
Sepsis 1 1
Perforation 1 1
Rash 1 1
Muscle Weakness 1 1
Nausea 1 1
Neuropathy 1 1
Vomiting 1 1
Dizziness 1 1
Anxiety 1 1
Distress 1 1
Tachycardia 1 1
Fungal Infection 1 1
Post Operative Wound Infection 1 1
Sedation 1 1
Alteration In Body Temperature 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
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
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