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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
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 6 6
Sharp Edges 4 4
Nonstandard Device 4 4
Entrapment of Device 3 3
Material Integrity Problem 3 3
Material Too Rigid or Stiff 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Inflation Problem 3 3
Failure to Disconnect 3 3
Malposition of Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Use of Device Problem 2 2
Appropriate Term/Code Not Available 2 2
Mechanical Problem 1 1
Crack 1 1
Collapse 1 1
Unintended Movement 1 1
Defective Device 1 1
Moisture Damage 1 1
Material Fragmentation 1 1
Unintended Ejection 1 1
Difficult or Delayed Positioning 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Migration 1 1
Suction Problem 1 1
Material Too Soft/Flexible 1 1
Improper or Incorrect Procedure or Method 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 61 61
No Known Impact Or Consequence To Patient 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Foreign Body In Patient 3 3
Insufficient Information 3 3
No Consequences Or Impact To Patient 3 3
No Code Available 2 2
Epistaxis 2 2
Discomfort 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
Hemorrhage/Bleeding 1 1
Respiratory Insufficiency 1 1
Airway Obstruction 1 1

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