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TPLC
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show TPLC since
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Device
needle, conduction, anesthetic (w/wo introducer)
Product Code
BSP
Regulation Number
868.5150
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANCORA MEDICAL TECHNOLOGY
SUBSTANTIALLY EQUIVALENT
1
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
3
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
DISCCATH LLC
SUBSTANTIALLY EQUIVALENT
1
DR. JAPAN CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
GLOBAL MEDIKIT LIMITED
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
SUBSTANTIALLY EQUIVALENT
1
MYCO MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
3
SUMMIT MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
2
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
69
69
2019
86
86
2020
77
77
2021
52
52
2022
83
83
2023
65
65
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
137
137
Leak/Splash
57
57
Fracture
28
28
Device Markings/Labelling Problem
23
23
Detachment of Device or Device Component
19
19
Loss of or Failure to Bond
17
17
Fluid/Blood Leak
14
14
Device Contamination with Chemical or Other Material
14
14
Defective Component
13
13
Packaging Problem
12
12
Complete Blockage
9
9
Failure To Adhere Or Bond
8
8
Material Separation
8
8
Material Integrity Problem
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Material Deformation
6
6
Material Twisted/Bent
6
6
Connection Problem
6
6
Defective Device
6
6
Entrapment of Device
6
6
Nonstandard Device
6
6
Crack
5
5
Disconnection
5
5
Device Handling Problem
5
5
Component Misassembled
4
4
Material Fragmentation
4
4
Patient-Device Incompatibility
4
4
Insufficient Flow or Under Infusion
4
4
No Flow
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Contamination /Decontamination Problem
3
3
Mechanical Problem
3
3
Difficult to Remove
3
3
Therapeutic or Diagnostic Output Failure
3
3
Output Problem
2
2
Material Split, Cut or Torn
2
2
Physical Resistance/Sticking
2
2
Unexpected Color
2
2
Air/Gas in Device
2
2
Lack of Effect
2
2
Off-Label Use
2
2
Product Quality Problem
2
2
Loose or Intermittent Connection
2
2
Incorrect Measurement
2
2
Contamination
2
2
Partial Blockage
2
2
Detachment Of Device Component
2
2
Improper or Incorrect Procedure or Method
2
2
Structural Problem
2
2
Failure to Deliver
2
2
Improper Flow or Infusion
2
2
Infusion or Flow Problem
2
2
Difficult to Open or Remove Packaging Material
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Device Operates Differently Than Expected
1
1
Device Damaged by Another Device
1
1
Difficult to Advance
1
1
Device Dislodged or Dislocated
1
1
Contamination of Device Ingredient or Reagent
1
1
Material Protrusion/Extrusion
1
1
Tear, Rip or Hole in Device Packaging
1
1
Dull, Blunt
1
1
Obstruction of Flow
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Incomplete or Missing Packaging
1
1
Failure to Advance
1
1
Physical Resistance
1
1
Device Or Device Fragments Location Unknown
1
1
Component Incompatible
1
1
Bent
1
1
Backflow
1
1
Material Discolored
1
1
Hole In Material
1
1
Labelling, Instructions for Use or Training Problem
1
1
Misconnection
1
1
Delivered as Unsterile Product
1
1
Material Rupture
1
1
Inadequacy of Device Shape and/or Size
1
1
Sticking
1
1
Unexpected Therapeutic Results
1
1
Separation Problem
1
1
Patient Device Interaction Problem
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
151
151
No Known Impact Or Consequence To Patient
97
97
Foreign Body In Patient
60
60
No Consequences Or Impact To Patient
43
43
Device Embedded In Tissue or Plaque
24
24
No Patient Involvement
24
24
Insufficient Information
13
13
No Information
13
13
No Code Available
7
7
Pain
7
7
Inadequate Pain Relief
4
4
Needle Stick/Puncture
3
3
Discomfort
2
2
Injury
2
2
Exposure to Body Fluids
2
2
Tissue Damage
2
2
Death
2
2
Headache
2
2
Hematoma
2
2
Patient Problem/Medical Problem
2
2
Blood Loss
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Abscess
1
1
Paresthesia
1
1
Hemorrhage/Bleeding
1
1
Tingling
1
1
Chills
1
1
Cardiac Arrest
1
1
Cerebrospinal Fluid Leakage
1
1
Underdose
1
1
Numbness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Feb-14-2020
2
Pajunk GmbH
II
Oct-29-2019
3
Smiths Medical ASD Inc.
II
Oct-19-2021
4
TELEFLEX MEDICAL INC
II
May-26-2020
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