TPLC - Total Product Life Cycle

• Device: airway, nasopharyngeal
• Regulation Description: Nasopharyngeal airway.
• Product Code: BTQ
• Regulation Number: 868.5100
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	13	13
2021	20	20
2022	20	20
2023	24	24
2024	22	22
2025	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Contamination /Decontamination Problem	41	41
Material Discolored	15	15
Moisture or Humidity Problem	14	14
Delivered as Unsterile Product	12	12
Migration or Expulsion of Device	5	5
Nonstandard Device	4	4
Material Integrity Problem	4	4
Sharp Edges	4	4
Material Too Rigid or Stiff	3	3
Failure to Disconnect	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Tear, Rip or Hole in Device Packaging	2	2
Packaging Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Use of Device Problem	2	2
Detachment of Device or Device Component	2	2
Material Fragmentation	1	1
Moisture Damage	1	1
Fitting Problem	1	1
Mechanical Problem	1	1
Inflation Problem	1	1
Malposition of Device	1	1
Device Handling Problem	1	1
Crack	1	1
Entrapment of Device	1	1
Material Too Soft/Flexible	1	1
Difficult or Delayed Positioning	1	1
Collapse	1	1
Defective Device	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	87	87
No Known Impact Or Consequence To Patient	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Insufficient Information	3	3
Epistaxis	2	2
Vomiting	1	1
Foreign Body In Patient	1	1
Hemostasis	1	1
Aspiration/Inhalation	1	1
Respiratory Distress	1	1
Unspecified Tissue Injury	1	1
Discomfort	1	1
Inflammation	1	1
Hemorrhage/Bleeding	1	1
Convulsion/Seizure	1	1
Respiratory Insufficiency	1	1
Hypersensitivity/Allergic reaction	1	1

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