Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
catheter, conduction, anesthetic
Product Code
BSO
Regulation Number
868.5120
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
93
93
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
756
756
Obstruction of Flow
85
85
Fluid/Blood Leak
68
68
Detachment of Device or Device Component
66
66
Difficult to Advance
66
66
Material Twisted/Bent
49
49
No Flow
47
47
Material Separation
40
40
Failure to Advance
25
25
Physical Resistance/Sticking
20
20
Adverse Event Without Identified Device or Use Problem
19
19
Difficult to Remove
19
19
Material Fragmentation
18
18
Material Split, Cut or Torn
17
17
Disconnection
12
12
Leak/Splash
11
11
Crack
10
10
Unsealed Device Packaging
10
10
Fracture
9
9
Stretched
8
8
Activation, Positioning or Separation Problem
7
7
Material Integrity Problem
7
7
Burst Container or Vessel
5
5
Material Rupture
5
5
Defective Device
5
5
Shipping Damage or Problem
5
5
Loose or Intermittent Connection
4
4
Packaging Problem
4
4
Component Missing
4
4
Premature Separation
3
3
Material Too Soft/Flexible
3
3
Product Quality Problem
3
3
Unraveled Material
3
3
Entrapment of Device
3
3
Material Puncture/Hole
3
3
Complete Blockage
3
3
Device Damaged Prior to Use
3
3
Dull, Blunt
2
2
Separation Problem
2
2
Mechanical Jam
2
2
Contamination
2
2
Defective Component
2
2
Unintended Movement
2
2
Gas/Air Leak
2
2
Mechanical Problem
2
2
Connection Problem
2
2
Flushing Problem
2
2
Device Dislodged or Dislocated
2
2
Material Deformation
2
2
Device Contamination with Body Fluid
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
526
526
No Clinical Signs, Symptoms or Conditions
316
316
No Consequences Or Impact To Patient
233
233
Foreign Body In Patient
94
94
No Information
62
62
Insufficient Information
46
46
Not Applicable
33
33
Device Embedded In Tissue or Plaque
25
25
No Known Impact Or Consequence To Patient
23
23
Pain
17
17
Needle Stick/Puncture
10
10
Unspecified Infection
7
7
Headache
4
4
Inadequate Pain Relief
3
3
Bacterial Infection
3
3
Swelling/ Edema
3
3
No Code Available
3
3
Discomfort
3
3
Hemorrhage/Bleeding
2
2
Paresthesia
2
2
Spinal Column Injury
2
2
Embolism/Embolus
2
2
Hematoma
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Patient Problem/Medical Problem
2
2
Cellulitis
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Purulent Discharge
1
1
Burn(s)
1
1
Fever
1
1
Perforation
1
1
Vomiting
1
1
Muscle Weakness
1
1
Awareness during Anaesthesia
1
1
Dyspnea
1
1
Abscess
1
1
Sedation
1
1
Tachycardia
1
1
Unspecified Tissue Injury
1
1
Fungal Infection
1
1
Cerebrospinal Fluid Leakage
1
1
Convulsion/Seizure
1
1
Sepsis
1
1
Decreased Sensitivity
1
1
Hypersensitivity/Allergic reaction
1
1
Neuropathy
1
1
Respiratory Insufficiency
1
1
Low Oxygen Saturation
1
1
Pulmonary Embolism
1
1
Distress
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
-
-