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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device airway, nasopharyngeal
Product CodeBTQ
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
Appropriate Term/Code Not Available 3 3
Inflation Problem 3 3
Material Integrity Problem 3 3
Component Missing 2 2
Use of Device Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Malposition of Device 2 2
Unintended Ejection 1 1
Difficult to Insert 1 1
Material Fragmentation 1 1
Fail-Safe Design Failure 1 1
Moisture Damage 1 1
Defective Device 1 1
Difficult or Delayed Positioning 1 1
Unintended Movement 1 1
Collapse 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Markings/Labelling Problem 1 1
Migration 1 1
Device Operates Differently Than Expected 1 1
Crack 1 1
Suction Problem 1 1
Material Too Soft/Flexible 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Problem 1 1
Deformation Due to Compressive Stress 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
Hemostasis 1 1
Choking 1 1
Convulsion/Seizure 1 1
Respiratory Insufficiency 1 1
Airway Obstruction 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Mar-21-2017
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