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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
2017 3 3
2018 3 3
2019 75 75
2020 13 13
2021 20 20
2022 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Moisture or Humidity Problem 73 73
Contamination /Decontamination Problem 13 13
Migration or Expulsion of Device 7 7
Detachment of Device or Device Component 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Sharp Edges 4 4
Material Integrity Problem 3 3
Appropriate Term/Code Not Available 2 2
Inflation Problem 2 2
Component Missing 2 2
Entrapment of Device 2 2
Fail-Safe Design Failure 1 1
Unintended Ejection 1 1
Collapse 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Nonstandard Device 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1
Difficult to Insert 1 1
Unintended Movement 1 1
Device Markings/Labelling Problem 1 1
Migration 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 64 64
No Clinical Signs, Symptoms or Conditions 30 30
No Known Impact Or Consequence To Patient 11 11
Foreign Body In Patient 4 4
No Consequences Or Impact To Patient 3 3
No Code Available 3 3
Discomfort 2 2
Choking 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Hemorrhage/Bleeding 1 1
Hemostasis 1 1
Hypersensitivity/Allergic reaction 1 1
Respiratory Distress 1 1
Vomiting 1 1
Insufficient Information 1 1

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