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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
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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