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TPLC
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show TPLC since
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Device
catheter, conduction, anesthetic
Product Code
BSO
Regulation Number
868.5120
Device Class
2
Premarket Reviews
Manufacturer
Decision
CIMPAX APS
SUBSTANTIALLY EQUIVALENT
1
EPIMED INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
1
HK SURGICAL
SUBSTANTIALLY EQUIVALENT
1
IMEDICOM CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PAJUNK GMBH MEDIZINTECHNOLOGIE
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
80
80
2019
779
779
2020
159
159
2021
145
145
2022
138
138
2023
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
736
736
Obstruction of Flow
81
81
Detachment of Device or Device Component
70
70
Fluid/Blood Leak
57
57
Difficult to Advance
55
55
No Flow
46
46
Material Twisted/Bent
39
39
Adverse Event Without Identified Device or Use Problem
25
25
Failure to Advance
24
24
Physical Resistance/Sticking
21
21
Material Split, Cut or Torn
19
19
Difficult to Remove
17
17
Material Separation
15
15
Material Fragmentation
15
15
Disconnection
13
13
Fracture
12
12
Leak/Splash
12
12
Unsealed Device Packaging
10
10
Crack
10
10
Device Handling Problem
8
8
Activation, Positioning or Separation Problem
7
7
Premature Separation
7
7
Defective Device
6
6
Material Integrity Problem
6
6
Stretched
6
6
Shipping Damage or Problem
5
5
Burst Container or Vessel
5
5
Component Missing
5
5
Device Damaged by Another Device
4
4
Device Dislodged or Dislocated
4
4
Packaging Problem
4
4
Loose or Intermittent Connection
4
4
Product Quality Problem
3
3
Entrapment of Device
3
3
Material Rupture
3
3
Device Damaged Prior to Use
3
3
Device Issue
3
3
Device Contamination with Body Fluid
2
2
Connection Problem
2
2
Patient Device Interaction Problem
2
2
Material Too Soft/Flexible
2
2
Material Deformation
2
2
Mechanical Jam
2
2
Complete Blockage
2
2
Kinked
2
2
Contamination
2
2
Flushing Problem
2
2
Material Puncture/Hole
2
2
Mechanical Problem
2
2
Separation Problem
2
2
Delivered as Unsterile Product
1
1
Device Emits Odor
1
1
Peeled/Delaminated
1
1
Off-Label Use
1
1
Retraction Problem
1
1
Unraveled Material
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Difficult to Flush
1
1
Difficult to Insert
1
1
Detachment Of Device Component
1
1
Cross Reactivity
1
1
Device Contamination with Chemical or Other Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Difficult to Open or Close
1
1
Sharp Edges
1
1
Device Fell
1
1
Positioning Problem
1
1
Pressure Problem
1
1
Appropriate Term/Code Not Available
1
1
Contamination /Decontamination Problem
1
1
Physical Resistance
1
1
Failure to Deliver
1
1
Tear, Rip or Hole in Device Packaging
1
1
Structural Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
526
526
No Consequences Or Impact To Patient
265
265
No Clinical Signs, Symptoms or Conditions
224
224
No Information
76
76
Foreign Body In Patient
68
68
Not Applicable
33
33
No Known Impact Or Consequence To Patient
31
31
Insufficient Information
29
29
Device Embedded In Tissue or Plaque
27
27
Pain
14
14
Unspecified Infection
7
7
No Code Available
7
7
Awareness during Anaesthesia
5
5
Needle Stick/Puncture
5
5
Discomfort
3
3
Bacterial Infection
3
3
Death
3
3
Headache
3
3
Patient Problem/Medical Problem
3
3
Swelling/ Edema
3
3
Embolism/Embolus
2
2
Hematoma
2
2
Hemorrhage/Bleeding
2
2
Fever
2
2
Cardiac Arrest
2
2
Toxicity
2
2
Inadequate Pain Relief
2
2
Reaction
2
2
Spinal Column Injury
2
2
Tachycardia
1
1
Tissue Damage
1
1
Vasoconstriction
1
1
Vomiting
1
1
Sepsis
1
1
Distress
1
1
Fungal Infection
1
1
Post Operative Wound Infection
1
1
Sedation
1
1
Low Oxygen Saturation
1
1
Underdose
1
1
Cardiopulmonary Arrest
1
1
Cellulitis
1
1
Purulent Discharge
1
1
Dyspnea
1
1
Burn(s)
1
1
Pulmonary Embolism
1
1
Abscess
1
1
Fistula
1
1
Muscle Weakness
1
1
Nausea
1
1
Hypersensitivity/Allergic reaction
1
1
Respiratory Insufficiency
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Unspecified Tissue Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Thromboembolism
1
1
Convulsion/Seizure
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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