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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
CIMPAX APS
  SUBSTANTIALLY EQUIVALENT 1
EPIMED INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 779 779
2020 159 159
2021 146 146
2022 135 135
2023 80 80
2024 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Break 746 746
Obstruction of Flow 84 84
Detachment of Device or Device Component 66 66
Difficult to Advance 63 63
Fluid/Blood Leak 63 63
Material Twisted/Bent 49 49
No Flow 47 47
Material Separation 30 30
Failure to Advance 25 25
Adverse Event Without Identified Device or Use Problem 18 18
Physical Resistance/Sticking 18 18
Difficult to Remove 18 18
Material Fragmentation 17 17
Material Split, Cut or Torn 17 17
Disconnection 12 12
Crack 10 10
Unsealed Device Packaging 10 10
Fracture 9 9
Leak/Splash 9 9
Stretched 8 8
Material Integrity Problem 7 7
Activation, Positioning or Separation Problem 7 7
Shipping Damage or Problem 5 5
Burst Container or Vessel 5 5
Loose or Intermittent Connection 4 4
Material Rupture 4 4
Packaging Problem 4 4
Component Missing 4 4
Defective Device 4 4
Material Too Soft/Flexible 3 3
Device Damaged Prior to Use 3 3
Product Quality Problem 3 3
Complete Blockage 3 3
Entrapment of Device 3 3
Premature Separation 3 3
Contamination 2 2
Flushing Problem 2 2
Material Puncture/Hole 2 2
Defective Component 2 2
Unraveled Material 2 2
Mechanical Jam 2 2
Separation Problem 2 2
Material Deformation 2 2
Device Dislodged or Dislocated 2 2
Dull, Blunt 2 2
Connection Problem 2 2
Device Contamination with Body Fluid 2 2
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Disconnect 1 1
Structural Problem 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Difficult to Open or Close 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Pressure Problem 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Sharp Edges 1 1
Device Fell 1 1
Improper or Incorrect Procedure or Method 1 1
Difficult to Insert 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Pumping Stopped 1 1
Difficult to Flush 1 1
Delivered as Unsterile Product 1 1
Device Emits Odor 1 1
Corroded 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 526 526
No Clinical Signs, Symptoms or Conditions 295 295
No Consequences Or Impact To Patient 233 233
Foreign Body In Patient 81 81
No Information 62 62
Insufficient Information 43 43
Not Applicable 33 33
Device Embedded In Tissue or Plaque 25 25
No Known Impact Or Consequence To Patient 23 23
Pain 15 15
Unspecified Infection 7 7
Needle Stick/Puncture 7 7
Headache 4 4
Bacterial Infection 3 3
Discomfort 3 3
Swelling/ Edema 3 3
No Code Available 3 3
Inadequate Pain Relief 2 2
Patient Problem/Medical Problem 2 2
Embolism/Embolus 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Spinal Column Injury 2 2
Tachycardia 1 1
Vomiting 1 1
Perforation 1 1
Sepsis 1 1
Muscle Weakness 1 1
Neuropathy 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Awareness during Anaesthesia 1 1
Hypersensitivity/Allergic reaction 1 1
Burn(s) 1 1
Cellulitis 1 1
Cerebrospinal Fluid Leakage 1 1
Purulent Discharge 1 1
Dyspnea 1 1
Fever 1 1
Respiratory Insufficiency 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Unspecified Tissue Injury 1 1
Fungal Infection 1 1
Low Oxygen Saturation 1 1
Sedation 1 1
Distress 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 Epimed International II Aug-18-2021
5 Epimed International, Inc. II Mar-18-2021
6 Epimed International, Inc. II Jul-24-2019
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