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TPLC
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show TPLC since
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Device
airway, nasopharyngeal
Product Code
BTQ
Regulation Number
868.5100
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2016
3
3
2017
3
3
2018
3
3
2019
75
75
2020
13
13
2021
20
20
2022
20
20
2023
24
24
2024
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Moisture or Humidity Problem
75
75
Contamination /Decontamination Problem
40
40
Delivered as Unsterile Product
12
12
Material Discolored
10
10
Migration or Expulsion of Device
7
7
Detachment of Device or Device Component
7
7
Adverse Event Without Identified Device or Use Problem
5
5
Material Too Rigid or Stiff
5
5
Nonstandard Device
4
4
Sharp Edges
4
4
Entrapment of Device
3
3
Failure to Disconnect
3
3
Material Integrity Problem
3
3
Inflation Problem
3
3
Appropriate Term/Code Not Available
3
3
Malposition of Device
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Component Missing
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
1
1
Deformation Due to Compressive Stress
1
1
Unintended Ejection
1
1
Difficult to Insert
1
1
Material Fragmentation
1
1
Fail-Safe Design Failure
1
1
Moisture Damage
1
1
Unintended Movement
1
1
Collapse
1
1
Device Markings/Labelling Problem
1
1
Crack
1
1
Device Operates Differently Than Expected
1
1
Inadequacy of Device Shape and/or Size
1
1
Material Separation
1
1
Migration
1
1
Difficult or Delayed Positioning
1
1
Device Handling Problem
1
1
Packaging Problem
1
1
Defective Device
1
1
Mechanical Problem
1
1
Material Too Soft/Flexible
1
1
Suction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
77
77
No Patient Involvement
64
64
No Known Impact Or Consequence To Patient
11
11
Foreign Body In Patient
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
No Code Available
4
4
No Consequences Or Impact To Patient
4
4
Insufficient Information
3
3
Occlusion
2
2
Epistaxis
2
2
Discomfort
2
2
Hemorrhage/Bleeding
2
2
Hypersensitivity/Allergic reaction
1
1
Respiratory Distress
1
1
Aspiration/Inhalation
1
1
Vomiting
1
1
Choking
1
1
Hemostasis
1
1
Convulsion/Seizure
1
1
Respiratory Insufficiency
1
1
Low Oxygen Saturation
1
1
Airway Obstruction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Teleflex Medical
II
Mar-21-2017
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