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TPLC
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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
B. BRAUN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
2
B. BRAUN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
BAXANO, INC.
SUBSTANTIALLY EQUIVALENT
1
BUSSE HOSPITAL DISPOSABLES
SUBSTANTIALLY EQUIVALENT
1
CIMPAX APS
SUBSTANTIALLY EQUIVALENT
1
1. K191470
C-CAT Anaesthesia Catheter kit
EPIMED INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
1
EPIMED INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
FERROSAN MEDICAL DEVICES SP. Z O.O.
SUBSTANTIALLY EQUIVALENT
1
HALYARD HEALTH
SUBSTANTIALLY EQUIVALENT
1
HK SURGICAL
SUBSTANTIALLY EQUIVALENT
1
IMEDICOM CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
KIMBERLY-CLARK CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
2
PAJUNK GMBH MEDIZINTECHNOLOGIE
SUBSTANTIALLY EQUIVALENT
2
PLAN 1 HEALTH, S.R.L.
SUBSTANTIALLY EQUIVALENT
1
SUMMIT MEDICAL PRODUCTS, INC
SUBSTANTIALLY EQUIVALENT
2
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL , INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX, INC.
SUBSTANTIALLY EQUIVALENT
1
VITAL 5
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
45
45
2015
43
43
2016
71
71
2017
38
38
2018
80
80
2019
779
779
2020
159
159
2021
146
146
2022
135
135
2023
80
80
2024
39
39
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
811
811
Obstruction of Flow
91
91
Detachment of Device or Device Component
75
75
Fluid/Blood Leak
67
67
Difficult to Advance
65
65
No Flow
53
53
Adverse Event Without Identified Device or Use Problem
53
53
Material Twisted/Bent
47
47
Material Separation
30
30
Device Handling Problem
28
28
Physical Resistance/Sticking
27
27
Failure to Advance
25
25
Difficult to Remove
24
24
Material Fragmentation
23
23
Device Operates Differently Than Expected
22
22
Material Split, Cut or Torn
19
19
Fracture
18
18
Disconnection
17
17
Torn Material
17
17
Device Damaged by Another Device
16
16
Leak/Splash
15
15
Stretched
14
14
Split
14
14
Detachment Of Device Component
12
12
Human Factors Issue
12
12
Improper or Incorrect Procedure or Method
11
11
Entrapment of Device
10
10
Crack
10
10
Unsealed Device Packaging
10
10
Use of Device Problem
9
9
Retraction Problem
8
8
Device Issue
8
8
Loose or Intermittent Connection
8
8
Material Integrity Problem
8
8
Activation, Positioning or Separation Problem
7
7
Premature Separation
7
7
Defective Device
7
7
Component Missing
6
6
Positioning Problem
6
6
Device Dislodged or Dislocated
6
6
Connection Problem
5
5
Patient-Device Incompatibility
5
5
Product Quality Problem
5
5
Shipping Damage or Problem
5
5
Burst Container or Vessel
5
5
Failure To Adhere Or Bond
4
4
Mechanical Problem
4
4
Kinked
4
4
Material Rupture
4
4
Device Or Device Fragments Location Unknown
4
4
Physical Resistance
4
4
Packaging Problem
4
4
Appropriate Term/Code Not Available
3
3
Material Too Soft/Flexible
3
3
Material Deformation
3
3
Mechanical Jam
3
3
Failure to Deliver
3
3
Unraveled Material
3
3
Device Damaged Prior to Use
3
3
Defective Component
3
3
Labelling, Instructions for Use or Training Problem
3
3
Contamination
3
3
Inaccurate Flow Rate
3
3
Flushing Problem
2
2
Complete Blockage
2
2
Difficult to Insert
2
2
Material Puncture/Hole
2
2
Difficult To Position
2
2
Increase in Pressure
2
2
Tip breakage
2
2
Device, or device fragments remain in patient
2
2
Device Slipped
2
2
Sticking
2
2
Device Contamination with Body Fluid
2
2
Dull, Blunt
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Device-Device Incompatibility
2
2
Separation Problem
2
2
Patient Device Interaction Problem
2
2
Migration
1
1
Unintended Movement
1
1
Insufficient Information
1
1
Pressure Problem
1
1
Sharp Edges
1
1
Device Fell
1
1
Difficult to Open or Close
1
1
Device Markings/Labelling Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Failure to Disconnect
1
1
Contamination /Decontamination Problem
1
1
Failure to Infuse
1
1
Tear, Rip or Hole in Device Packaging
1
1
Cut In Material
1
1
Structural Problem
1
1
Uncoiled
1
1
Device Inoperable
1
1
Off-Label Use
1
1
Pumping Stopped
1
1
Peeled/Delaminated
1
1
Material Frayed
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
528
528
No Consequences Or Impact To Patient
293
293
No Clinical Signs, Symptoms or Conditions
286
286
No Information
103
103
Foreign Body In Patient
101
101
Device Embedded In Tissue or Plaque
71
71
No Known Impact Or Consequence To Patient
63
63
Insufficient Information
43
43
Not Applicable
33
33
Unspecified Infection
31
31
Pain
24
24
Awareness during Anaesthesia
19
19
No Code Available
14
14
Inadequate Pain Relief
7
7
Needle Stick/Puncture
7
7
Erythema
6
6
Bacterial Infection
5
5
Headache
4
4
Reaction
4
4
Discomfort
4
4
Tissue Damage
3
3
Patient Problem/Medical Problem
3
3
Fever
3
3
Swelling
3
3
Death
3
3
Purulent Discharge
3
3
Swelling/ Edema
3
3
Spinal Column Injury
2
2
Cellulitis
2
2
Itching Sensation
2
2
Rash
2
2
Local Reaction
2
2
Hematoma
2
2
Hemorrhage/Bleeding
2
2
Hemothorax
2
2
Cardiac Arrest
2
2
Skin Inflammation
2
2
Pregnancy
2
2
Embolism/Embolus
2
2
Toxicity
2
2
Injury
2
2
Other (for use when an appropriate patient code cannot be identified)
2
2
Anxiety
1
1
Distress
1
1
Sedation
1
1
Vomiting
1
1
Dizziness
1
1
Fungal Infection
1
1
Low Oxygen Saturation
1
1
Decreased Respiratory Rate
1
1
Underdose
1
1
Respiratory Insufficiency
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Unspecified Tissue Injury
1
1
Convulsion/Seizure
1
1
Post Operative Wound Infection
1
1
Alteration In Body Temperature
1
1
Test Result
1
1
Cardiopulmonary Arrest
1
1
Wound Dehiscence
1
1
Pulmonary Embolism
1
1
Abscess
1
1
Exposure to Body Fluids
1
1
Burn(s)
1
1
Hypersensitivity/Allergic reaction
1
1
High Blood Pressure/ Hypertension
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Sepsis
1
1
Tachycardia
1
1
Perforation
1
1
Muscle Weakness
1
1
Nausea
1
1
Neuropathy
1
1
Cerebrospinal Fluid Leakage
1
1
Dyspnea
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
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
8
I-Flow LLC
II
Jun-03-2013
9
Smiths Medical ASD, Inc.
III
Sep-03-2009
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