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TPLC
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Device
catheter, conduction, anesthetic
Regulation Description
Anesthesia conduction catheter.
Product Code
BSO
Regulation Number
868.5120
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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