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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device airway, nasopharyngeal
Regulation Description Nasopharyngeal airway.
Product CodeBTQ
Regulation Number 868.5100
Device Class 1

MDR Year MDR Reports MDR Events
2021 20 20
2022 20 20
2023 24 24
2024 22 22
2025 60 60
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination /Decontamination Problem 49 49
Material Discolored 39 39
Delivered as Unsterile Product 12 12
Moisture or Humidity Problem 9 9
Defective Component 8 8
Failure to Disconnect 5 5
Sharp Edges 4 4
Packaging Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Nonstandard Device 4 4
Entrapment of Device 2 2
Physical Resistance/Sticking 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Fitting Problem 1 1
Break 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Malposition of Device 1 1
Contamination 1 1
Moisture Damage 1 1
Difficult to Remove 1 1
Material Fragmentation 1 1
Gas/Air Leak 1 1
Inflation Problem 1 1
Device Handling Problem 1 1
Difficult or Delayed Separation 1 1
Detachment of Device or Device Component 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 124 124
Insufficient Information 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Epistaxis 2 2
Hypersensitivity/Allergic reaction 1 1
Aspiration/Inhalation 1 1
Inflammation 1 1
Foreign Body In Patient 1 1
Vomiting 1 1
Discomfort 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Convulsion/Seizure 1 1
Hemorrhage/Bleeding 1 1
Respiratory Insufficiency 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. II Oct-23-2024
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