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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 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Break 740 740
Obstruction of Flow 84 84
Detachment of Device or Device Component 66 66
Difficult to Advance 63 63
Fluid/Blood Leak 61 61
No Flow 47 47
Material Twisted/Bent 39 39
Failure to Advance 25 25
Material Separation 22 22
Adverse Event Without Identified Device or Use Problem 18 18
Physical Resistance/Sticking 18 18
Material Split, Cut or Torn 17 17
Difficult to Remove 17 17
Material Fragmentation 17 17
Disconnection 11 11
Crack 10 10
Unsealed Device Packaging 10 10
Fracture 9 9
Leak/Splash 9 9
Material Integrity Problem 7 7
Activation, Positioning or Separation Problem 7 7
Stretched 7 7
Burst Container or Vessel 5 5
Shipping Damage or Problem 5 5
Component Missing 4 4
Loose or Intermittent Connection 4 4
Defective Device 4 4
Packaging Problem 4 4
Material Too Soft/Flexible 3 3
Premature Separation 3 3
Device Damaged Prior to Use 3 3
Entrapment of Device 3 3
Material Rupture 3 3
Product Quality Problem 3 3
Material Puncture/Hole 2 2
Device Contamination with Body Fluid 2 2
Complete Blockage 2 2
Contamination 2 2
Flushing Problem 2 2
Connection Problem 2 2
Separation Problem 2 2
Material Deformation 2 2
Mechanical Jam 2 2
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
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Failure to Disconnect 1 1
Unraveled Material 1 1
Improper or Incorrect Procedure or Method 1 1
Structural Problem 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
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Difficult to Insert 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Pumping Stopped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 526 526
No Clinical Signs, Symptoms or Conditions 272 272
No Consequences Or Impact To Patient 233 233
Foreign Body In Patient 77 77
No Information 62 62
Insufficient Information 40 40
Not Applicable 33 33
Device Embedded In Tissue or Plaque 25 25
No Known Impact Or Consequence To Patient 23 23
Pain 14 14
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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